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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00444-1
Product Name/Description Monolisa HCV Ag-Ab ULTRA V2 assay. An in vitro diagnostic medical device (IVD)

1 plate - 96 tests
Code Number: 72561
Lot Numbers: 6J0029 (Expiry 15 Feb 2018), 6K0030 (Expiry 28 Feb 2018), 6K0031 (Expiry 15 March 2018), 6M0032(Expiry 15 April 2018), 7A0033 (Expiry 30 May 2018)

5 plates - 480 tests
Code Number: 72562
Lot Numbers: 6J0533 (Expiry 15 Feb 2018), 6K0534 (Expiry 28 Feb 2018), 6K0535 (Expiry 15 March 2018), 6M0536 (Expiry 15 April 2018)

ARTG Number: 231015
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 3/04/2017
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue Bio-Rad Laboratories have noticed a decrease of all Optical Densities (OD) values for tested samples and controls. This could result in plate invalidation. Specific lots are affected by this phenomenon which causes a global decrease of all OD values appears some months after the manufacturing release of the lots. The reconstituted Antigen Positive Control - R5 is more impacted by the decrease of OD values and results in run invalidation when its OD becomes lower than 0.5. However, since final results (ratios) are not impacted, there is no risk of an erroneous result.
Recall Action Recall for Product Correction
Recall Action Instructions Users are asked to;
· To continue to use kits and lots in table 1 as long as the validation criteria are met (refer to product package insert (section 7.5) for detailed instructions):

1) For the negative control R3: O.D. < cut off x 0.6
2) For the antibodies positive control R4: 0.800 = Mean O.D. = 2.700
3) For the working solution R5: O.D. > 0.500

· To stop using kits of lots in table 1 if validation criteria failed. In that case, discard the kit, fill the Annex 1 Customer Response Form and return it to your customer service to obtain replacement kits.
This action has been closed-out on 22/03/2018.
Contact Information 1800 224 354 - Bio-Rad Laboratories