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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01041-1
Product Name/Description BK Virus R-gene Real-time Detection and Quantification Kit (used to measure the viral load of BK virus in whole blood, plasma and urine samples). An in vitro diagnostic medical device (IVD).

Catalogue Number: 69-013B

Lot Numbers:
1003909940, expiry 12-03-2017
1004754140, expiry 04-02-2018
1004764070, expiry 04-02-2018

ARTG Number: 211361
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/08/2016
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue Following a customer complaint about difficulties to interpret low viral load in whole blood samples, a bioMérieux investigation showed that the sensitivity of the BK Virus R-gene of 260 copies/mL (corresponding to 2.41 log10) claimed in the IFU for whole blood was not confirmed. A Limit of Detection (LOD) experiment conducted with whole blood samples has led to a LOD value of 1578 copies/mL (corresponding to 3.20 log10).

The issue only impacts whole blood samples with a low viral load (260 to 1578 copies/mL), where amplification leads to creeping/flat amplification curves that are difficult to interpret. These problems of interpretation could lead to:
- a false negative result,
- a delayed result until a new run or a new test is performed.

This issue has no impact on negative results or on high positive samples, as the amplification curves are well identified and also, does not impact the test when urine or plasma samples are used.
Recall Action Recall for Product Correction
Recall Action Instructions bioMérieux is advising users that the Limit of Detection (LOD) is 1578 copies/mL rather than 260 copies/mL for whole blood samples until the root cause is identified and corrected. In addition, bioMérieux is advising that in case of doubt or for attended low viral load samples, testing should be performed on plasma or urine samples instead whole blood samples.

Any concerns regarding previously reported results should be discussed with the Laboratory/Medical Director to determine the appropriate course of action. Following the completion of the manufacturer’s investigation, further actions may be undertaken.

This action has been closed out on 04/03/2019
Contact Information 1800 333 421 - bioMérieux Technical Assistance