Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 3, 2013
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
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. T…
Genetic Testing Institute,inc recalled Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is design… - a moderate-severity action.
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is design… was recalled by Genetic Testing Institute,inc in April 3, 2013. Reason: Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicat…. Check the official notice for the remedy. Verify recall #Z-1022-2013 with the FDA Devices before acting.
The recall
Genetic Testing Institute,inc issued this moderate-severity FDA Devices recall-Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicat….
- Moderate
- severity level
- Class II
- classification
- April 3, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1022-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1022-2013) was formally reported on April 3, 2013, with the manufacturer initiating the action on February 4, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Genetic Testing Institute,inc is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 386 kits (370 US, 16 OUS).
The documented reason for this recall is: 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 i… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
386 kits (370 US, 16 OUS)
Related Recalls
6
3 from same agency
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).
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1022-2013 |
| Date reported | April 3, 2013 |
| Date initiated | February 4, 2013 |
| Recalling firm | Genetic Testing Institute,inc |
| Firm location | Waukesha, WI |
| Affected scope | 386 kits (370 US, 16 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1022-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).. Recalled by Genetic Testing Institute,inc. Units affected: 386 kits (370 US, 16 OUS).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-1022-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1022-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 3, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.