PCRopsis Reagent Buccal — Class II medical device recall Z-1296-2023
Ongoing recall by Entopsis , Inc., reported 2023-04-05, distributed nationwide. Presence of misleading label statements on the product label.
| Recall number | Z-1296-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Entopsis , Inc., Medley, FL, United States |
| Recall initiated | 2023-02-21 |
| Classified | 2023-03-29 |
| Reported by FDA | 2023-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CO, DE, DK, ES, GB, KR, LT, PT |
| Quantity | 6 units |
| Reason classes | labeling |
| Model numbers | 282001 |
| Expiration dates | 2023-08 |
Product
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
Reason for recall
Presence of misleading label statements on the product label.
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-1296-2023. 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.