|
27 October 2006
Product Recall Notice
In vitro Diagnostic Device Recall
Product : CoaguChekÒ PT-Test 12 Tests Cat. No. 1 1937634190
and
CoaguChekÒ PT-Test 48 Tests Cat. No. 1 1937642190
Batch/Lot No. : All current strips
Recall Reason : CoaguChek PT Test Strips – Potential for Erroneous Patient Results Due
to Manufacturing Issue
In rare, isolated cases, use of test strips of the above-named product and pack sizes may result in falsely elevated INR values.
The cause of this error is a production problem. During the coating process in production it is possible that a reduced amount of an active ingredient is applied to the test strips which can lead to falsely elevated INR values. The occurrence of this error is random with an extremely low error frequency (0.001% - this means that in N.Z. we may encounter 1 affected strip per year). Corrective actions have already been taken which will ensure that the coating on each strip is appropriate. Unfortunately it will take some months until this new process is finally established and test strips without this potential defect are available.
Although the likelihood that you have received such faulty test strips is minimal, we have decided for the sake of your safety, that duplicate testing using different lot numbers - or alternatively different rolls - should be performed whenever you are running a test with your CoaguChek® or CoaguChek® S instrument.
Health risk :
In rare isolated cases, use of test strips of the above-named product and pack sizes may result in falsely elevated INR values.
Action to be taken by recipient :
- Please find below pictures on how to identify the lot number and roll number, respectively on the test strip box and on the test strip pouch.
- In case you do not have strips from two different lots or rolls please contact Roche Diagnostics for another CoaguChek® PT test strip box which will be delivered free of charge.
- The reason for the second test is to ensure the first test is correct.
- Once you have performed the two tests, refer to the attached guide to determine the allowable differences between your results.
- If the second result falls within the acceptable range, this will ensure correctness of your first test.
- If the second result is not within this acceptable range do not initiate treatment until you confirm the test result with an alternative method. Prior to any additional testing contact Roche Diagnostics at 0508 69 5433 for further instructions and to report this discrepancy.
- If you have any concerns regarding your treatment, please consult your physician.
- The duplicate testing has to be done until strips without this potential defect are available. Shipment of replacement strips will start in January 2007.
CoaguChek® PT Test
How to identify the lot number and roll number
|
|
CoaguChek® PT Test
Test strip box
Lot number: e.g. 101ARoll number: e.g. D 1 |
CoaguChek® PT Test
Test strip pouch
Lot number: e.g. 101A Roll number: e.g. D 1 |
Note: Always follow package insert instructions to avoid erroneous test results or test errors
from other causes.
Alternatively you can elect to discontinue using your CoaguChek® or CoaguChek® S system until the strips without the defect are available in January and use your local laboratory service.
Please note: The CoaguChek XS® system is not affected by this issue. If you have upgraded to a CoaguChek XS® duplicate testing is not required.
If you have any questions regarding the recall, please contact our customer service centre at the following number 0508 MY LIFE (0508 69 5433).
Please complete the acknowledgement form below and return to RDNZ.
Details of Compensation:
As already mentioned above the additional costs for the duplicate testing will be covered by Roche Diagnostics.
This removal action has been taken after consultation with the Ministry of Health.
We apologise for any inconvenience this may cause and hope for your understanding.
B. McEwen B. Sheppard
Manager Regulatory Affairs Product Manager Coagulation |
