Device Alerts

This page displays an alert history with current and active alerts listed from the top of the page.
Click on the below documents links to review details.


Recall
Action Commencement
Notifier  Reference                       Type Description & Notice                                                      Vendor Ref. No. Status
23 July 2021
TGA RC-2021-RN-01591-1 Product Notification Open vials of Accu-Chek Inform II test strips   Open
Roche has received complaints from one hospital in the United States alleging unexpected results (such as positively biased, or falsely high results) when using test strip vials which have opened while still in a sealed carton. This could happen to Accu-Chek Inform II test strips, when they are shipped at elevated temperature (>45ºC or 113ºF) and when the carton is dropped or handled roughly during transit and distribution process. It is only when these two conditions occur in combination that the failure mode has been observed. Due to the influence of high temperature and humidity, this failure might affect the accuracy of the blood glucose measurement.
Roche is updating product labelling to clarify instructions for handling vials that have opened within sealed cartons and will provide test strip replacements to users who have purchased test strip vials that have opened while still in a sealed carton. Please contact your local supplier.
8 April 2021  TGA RC-2021-RN-00901-1 Urgent Product Defect
Correction
ABL90 FLEX and ABL90 FLEX
PLUS with E3800 CPU unit
915-416
Open
ABL90 FLEX and ABL90 FLEX PLUS with E3800 CPU unit - risk of incorrect time and potentially biased results.
Please contact the manufacturer directly if assistance is required.
The vendor has advised the following NSW Health Pathology sites are affected:
• Lismore - Theatres - Radiometer ABL90 - Serial number 393-090R0467N0009
• Grafton - Emergency Department - Radiometer ABL90 - Serial number 393-092R0048N002
• Grafton - ICU - Radiometer ABL90 - Serial number 393-092R0048N001
• Maitland - ICU - Radiometer ABL90 Flex Plus - Serial number I393-092R0202N0004
• John Hunter Hospital - RNC - Radiometer ABL90 Flex - Serial number I393-092R0211N0005
• Gosford - Maternity - Radiometer ABL90 Flex Plus - Serial number I393-092R0088N0003
• Gosford - Theatres - Radiometer ABL90 Flex Plus - Serial number I393-092R0144N0016
• Gosford - Special Care Nursery - Radiometer ABL90 Flex Plus - Serial number I393-092R0160N0010
• Gosford - Respiratory - Radiometer ABL90 Flex Plus - Serial number I393-092R0210n0031
 
24 March 2021
TGA RC-2021-N-00802-1 Urgent Medical Device Recall  PIC070 Arterial Blood Samplers
915-415  Open 
Radiometer has advised of an issue with the PIC070 Arterial Blood Sampler.  The issue relates to the sterile barrier system for the product.  The vendor requests that the following affected products are not used:
• 956-518 PIC070 w/o needle
• 956-519 PIC070 w/o needle
• 956-522 PIC070 22G x 25mm
• 956-525 PIC070 22G x 32mm
• 956-529 PIC070 23G x 16mm
• 956-533 PIC070 23G x 25mm
• 956-534 PIC070 23G x 32mm
• 956-547 PIC070 25G x 16mm
The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection.  The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock.  Immunosuppressed patients are at particular risk.  
Radiometer and HealthShare are working on replacing affected products and will be in contact with customers with affected products and suitable alternatives. 
6 January 2021
TGA RC-2020-RN-01534-1 Product Defect Correction i-STAT CG8+ cartridges
i-STAT EG7+ cartridges
 
03P88-25
03P76-25
Open
26 January 2021: NSW Health Pathology has been advised by Abbott Point of Care, manufacturer and supplier of the i-STAT device, of an instability issue with the ionized calcium (iCa) test on the CG8+ cartridge.  Until this is resolved iCa will be switched off on this cartridge type to avoid possible impact on patient diagnosis and treatment.  At present, it appears the iCa test on the CHEM8+ cartridge is unaffected and will remain an option.  We apologise for any inconvenience.

Abbott Point of Care has observed approximately 5.2% of cartridges are reporting higher than expected results for ionized calcium on some i-STAT CG8+ and EG7+ cartridges.  These may exhibit higher than expected reported results when stored at room temperature (18 to 30ºC) for periods of time.  It is recommended that these cartridges be use only:
• within 3 days of removal from refrigerated storage for lot numbers *20100 to *20339
• within 7 days of removal from refrigerated storage for lot numbers *20340 and above
Where * = lot letter A, K, L, M, N, W or Y.
10 December 2020 TGA   Product Defect Correction
ABL80 915-411 Open
Priority in January 2021 to complete upgrade at following sites:
• Prince of Wales Hospital (Respiratory Medicine) ABL80 FLEX BASIC
• Wyong Hospital (Respiratory) ABL80 FLEX BASIC
• Central Gosford Hospital (Respiratory Unit) ABL80 FLEX BASIC
• Central Gosford Hospital (Respiratory Unit) ABL80 FLEX CO-OX
• Wyong Hospital (Respiratory) ABL80 FLEX CO-OX

Radiometer is planning a software update to address this issue and will contact sites when a new software version is released.  Customer to ensure check digit is used with barcodes.
ABL80 series analysers may misinterpret a barcode label used for patient sample measurement if the barcode does not contain a check digit.
18 May 2020 TGA  RC-2020-RN-00432-1 Update ABL800
Blood Gas
Analyser
with FLEXQ
sampler tray
915-412 Open

8 March 2021: Ongoing with service teams part of service maintenance plan at following locations:
• Gosford Hospital (Pathology Department) - TBC
• Prince of Wales Hospital (Clinical Chemistry) - TBC
• Wollongong Hospital (Pathology Laboratory) - 4th week March
• Wollongong Hospital (Wgong ED) - 4th week of March
• Shoalhaven District Memorial Hospital (Pathology Laboratory) - TBC
• Shoalhaven District Memorial Hospital (ICU) - TBC
• Wollongong Hospital (ICU) - 4th week of March
• Tweed Heads District Hospital (Emergency) - TBC
• Royal Prince Alfred Hospital (ICU) - 8th March 
• Royal Prince Alfred Hospital (Emergency) - 8th March
• Royal Prince Alfred Hospital (Chris O'Brien Life House) - Week of 8th March


10 December 2020: Ongoing with service teams part of service maintenance plan at following locations:
• Blacktown Hospital (Respiratory Unit)
• Gosford Hospital (Pathology Department)
• Nepean Hospital (ICU)
• Prince of Wales Hospital (Clinical Chemistry)
• Hornsby & Kuring-Gai Hospital (ICU)
• Wyong Hospital (ICU)
• Bankstown Hospital (ICU)
• Royal Prince Alfred Hospital (Biochemistry Department)
• Concord Hospital (Diagnostic Pathology Unit)
• Concord Hospital (ICU)
• Prince of Wales Hospital (Clinical Chemistry)
• Wollongong Hospital (Pathology Laboratory)
• Wollongong Hospital (Wgong ED)
• Shoalhaven District Memorial Hospital (Pathology Laboratory)
• Shoalhaven District Memorial Hospital (ICU)
• Wollongong Hospital (ICU)
• Prince of Wales Hospital (Emergency)
• Tweed Heads District Hospital (Emergency)
• Wagga Wagga Rural Referral Hospital (Emergency)
• Royal Prince Alfred Hospital (ICU)
• Liverpool Hospital (Emergency)
• Royal Prince Alfred Hospital (Emergency)
• Royal Prince Alfred Hospital (Chris O'Brien Life House)
• Lismore Base Hospital (Accident and Emergency)

19 October 2020: Radiometer has release a new software version, V6.19 MR1, to correct this issue and will install the new software in your analyser.  You may now revoke the countermeasure, CM #1 or CM #2 put in place as per previous communication when the new software has been installed in your analyser.
18 May 2020: A risk of patient mix-up on ABL800 analysers with FLEXQ if set up in a certain manner and a specific sequence of events occurs.  Under NSW Health Pathology investigation.

15 April
2020 
TGA RC-2020-RN-00342-1  Product Defect Correction AQT90
Series
Analysers
915-404 Closed
10 December 2020: completed for NSW Health Pathology.
One NSW Health case site remains open at Bowral District Hospital Emergency Department. 
Software version 8.12.385.0 was released on 12 June 2020.
Radiometer is updating its software upgrade to V3.4MR2.  Customer to ensure check digit is used with barcodes.  NSW Health Pathology have requested regular updates.
2 April
2020
TGA RC-2020-RN-00310-1 Product Defect Correction Afinion
Analyser
Systems
Power

Closed
26 June 2020: all replacement power supplies have been shipped to the contact and an address provided on all returned confirmation forms.
The vendor has now received a signed form from all NSW Health Pathology sites.  No further action required.
Vendor to replace faulty parts which is expected to be sometime in May 2020.
17 March
2020
TGA   Recall Radiometer ClinicSafe tubes   Closed
Radiometer are replacing any unused customer stock.
NSW Health Pathology PoCT have requested regular updates. 
10 March
2020 
TGA RC-2020-RN-00142-1  Product Defect Correction Radiometer
ABL90/ABL90 Flex
Barcode
Reader
Defect
Correction
915-404 Closed
Software upgrade complete.  Completed for NSW Health Pathology.
Radiometer is updating its software upgrade to V3.4MR2.  Customer to ensure check digit is used with barcodes.  
NSW Health Pathology PoCT have requested regular updates. 
28 February
2020
TGA RC-2019-RN-01744-1 Update Radiometer
ABL90 Flex
and ABL90
Flex Plus
re hemolyser unit
915-400 Open
Issue open for these sites with estimated service date January 2021:
• Canterbury Hospital (Laboratory)
• Central Gosford Hospital (Maternity)
• Central Gosford Hospital (Operating Theatre)
• Fairfield District Hospital (Special Care Nursery)
• Grafton Base Hospital (HDU)
• Grafton Base Hospital (Emergency Dept)
• Prince of Wales Hospital (ICU)
• Prince of Wales Hospital (Cardiothoracic)
• RPA (Newborn Care Unit)
• RPA (Respiratory Investigation)
• St George Hospital (Respiratory Lung Function Laboratory)
• Wollongong Hospital (Operating Theatre)
Verify hemolyser run number and exchange where required. 
6 February
2020 
TGA   Product Defect Correction Abbott
iSTAT CHEM8+ and
Capillary
Specimens
  Open
NSW Health Pathology to remove cartridges from locations performing capillary testing.
29 November 2019 TGA RC-2019-RN-01744-1 Product Defect Correction  Radiometer
ABL's
reporting
negative
Bilirubin
values
  Closed
Radiometer is updating its software upgrade.  
NSW Health Pathology PoCT have requested regular updates.
13 November 2019  TGA    Recall Radiometer AQT90 Cleaning Solution Tubes   Closed
Radiometer are replacing any unused customer stock.
23 October
2019
TGA RC-2019-RN-01584-1 Product Defect Correction Radiometer
ABL8x7
Low
Creatinine
Results
  Closed
Completed for NSW Health Pathology.
Radiometer is updating its software upgrade to V6.18MR2.  NSW Health Pathology PoCT have requested regular updates.
6 May
2019 
TGA   Product Defect Correction Radiometer
ABL800
Series
Creatinine
Bias
Software upgrade to V6.18MR1.  Upgraded recall notice. Closed
Software upgrade to V6.18MR1.  Upgraded recall notice.