CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report
Gen-Probe Lifecodes PF4 Enhanced assay recalled
Genetic Testing Institute is recalling Gen-Probe Lifecodes PF4 Enhanced assay, distributed nationwide in the US. The recall was initiated on 4 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1022-2013
- FDA event ID
- 64501
- Recalling firm
- Genetic Testing Institute, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2013
- FDA classified
- 28 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Feb 2013 | Recall initiated by company | |
| 28 Mar 2013 | Classified by FDA | +52 days |
| 3 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
Questions about this recall
Is Gen-Probe Lifecodes PF4 Enhanced assay recalled?
Yes. Genetic Testing Institute recalled Gen-Probe Lifecodes PF4 Enhanced assay on 4 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-1022-2013.
Why was it 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
Which lots are affected?
Kit Lot Number 3000389
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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