Device product
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples
Z-1300-2023
Product summary
- Firm
- Entopsis , Inc.
- Event
- Event 91723
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 97 units
- Official record key
device-enforcement:Z-1300-2023
Official wording
Reason: Presence of misleading label statements on the product label.
Code information: a) REF 78378001, Lot Numbers: 4, Exp. 02/2023; 7, Exp. 07/2023; b) REF 78378025, Lot Numbers: 6, Exp. 06/2023; c) REF 78378100, Lot Numbers: 7, 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.