Device product
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
Z-1301-2023
Product summary
- Firm
- Entopsis , Inc.
- Event
- Event 91723
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 94 units
- Official record key
device-enforcement:Z-1301-2023
Official wording
Reason: Presence of misleading label statements on the product label.
Code information: a) REF 787001, Lot Numbers: 4, Exp. 05/2023; b) REF 787002, Lot Numbers: 4, Exp. 05/2023; 5, Exp. 07/2023; c) REF 787003, Lot Numbers: 5 Exp. 07/2023
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.