CF InPlex ASR Card — Class II medical device recall Z-1579-2016
Terminated recall by Hologic, Inc, reported 2016-05-04, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing durin
| Recall number | Z-1579-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2016-03-31 |
| Classified | 2016-04-27 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-08-09 |
| Distributed | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, WA, WV |
| Countries outside the US | CA |
| Quantity | 2,580 total |
| Reason classes | packaging |
| Lot numbers | U34XX, U35XX |
| Model numbers | 95-0501 |
Product
CF InPlex ASR Card; Catalog Number: 95-0501.
Reason for recall
Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1579-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.