| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00273-1 |
| Product Name/Description |
VerifyNow IIb/IIIa 25 Test and VerifyNow IIb/IIIa 10 Test (An in vitro Diagnostic Medical Device (IVD))
VerifyNow IIb/IIIa 25 Test
Catalogue No. AC85011
Lot: WC0180C
Lot Expiry: 21/10/2013
VerifyNow IIb/IIIa 10 Test
Catalogue No. AC85310
Lot: WC0182D
Lot Expiry: 8/7/2014 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Accumetrics, has determined that the referenced lot of these products may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. Lower than actual or expected PAU values may contribute to excess administration of IIb/IIIa antiplatelet agents. |
| Recall Action |
Recall |
| Recall Action Instructions |
Alere is advising their customers to discontinue use of the affected lots and dispose of any remaining tests. Replacement kits will be provided. Review of past results should be undertaken at the discretion of the Laboratory Medical Director or attending physician. |
| Contact Information |
07 3363 7711 - Alere Technical Support |