Device 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
Z-1298-2023
Product summary
- Firm
- Entopsis , Inc.
- Event
- Event 91723
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 363 units
- Official record key
device-enforcement:Z-1298-2023
Official wording
Reason: Presence of misleading label statements on the product label.
Code information: a) REF 597000, Lot Numbers: 2, Exp. 05/2024; 3, Exp. 6024; b) REF 597825, Lot Numbers: 5, Exp. 06/2024; c) REF 597850, Lot Numbers: 2, Exp. 05/2024; d) REF 5970025, Lot Numbers: 2, Exp. 05/2024; 3, Exp. 06/2024; 4, Exp. 06/2024; 5, Exp. 06/2024; e) REF 5971000, Lot Numbers: 4, Exp. 06/2024
Distribution pattern: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Derived failure modes
-
Unknown
Presence of misleading label statements on the product label.