Device product
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Z-1297-2023
Product summary
- Firm
- Entopsis , Inc.
- Event
- Event 91723
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 52 units
- Official record key
device-enforcement:Z-1297-2023
Official wording
Reason: Presence of misleading label statements on the product label.
Code information: a) REF 282001: Lot Numbers: 3, Exp. 05/2023; 4, Exp. 07/2023; b) REF 228002: Lot Numbers: 3, Exp. 05/2023; 4, Exp. 07/2023; 5, Exp. 04/2023
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.