Recall record at a glance
| Official record | Z-1022-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Genetic Testing Institute, Inc. |
| Report date | Apr 3, 2013 |
| Recall initiation date | Feb 4, 2013 |
| Quantity | 386 kits (370 US, 16 OUS) |
| Location | Waukesha, WI, United States |
Official product description
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Why the product was recalled
Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati
Distribution information
Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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