PCRopsis Lysis Beads — Class II medical device recall Z-1298-2023
Ongoing recall by Entopsis , Inc., reported 2023-04-05, distributed nationwide. Presence of misleading label statements on the product label.
| Recall number | Z-1298-2023 |
|---|---|
| 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 | 363 units |
| Reason classes | labeling |
| Lot numbers | 6024 |
| Model numbers | 597000, 5970025, 5971000, 597825, 597850 |
| Expiration dates | 2024-05, 2024-06 |
Product
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; 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-1298-2023. 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.