Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00084-2 |
Product Name/Description |
AcroMetrix PeliSpy Sero Control Type 36 and Type 38. An in vitro diagnostic medical device (IVD)
Type 36 Catalogue number: 964608 and S2381 Lot numbers: 201305 (Expiry date: 01/2014) and 035717 (Expiry date: 03/2013) Type 38 Catalogue number : 964609 and S2404 Lot numbers : 035716 (Expiry date: 01/2014) and 220905 (Expiry date: 08/2014)
ARTG Number: 192532 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
30/01/2013 |
Responsible Entity |
|
Reason/Issue |
The manufacturer of PeliSpy Sero Control Type 36 and Type 38 advises that affected lots may produce signal to cut-off (S/Co) ratios <1 when run on the PRISM HBsAg assay. Consequently, if these lots are implemented as a go-no-go control using a threshold S/Co ratio of 1 in the PRISM HBsAg assay, test runs may need to be failed. |
Recall Action |
Recall |
Recall Action Instructions |
Life Technologies is requesting users to inspect and quarantine any affected lots. Arrangements for stock recovery and replacement will be arranged upon confirmation of affected units. |
Contact Information |
1800 636 327 - Life Technologies Australia |