Device product
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
Z-1256-2019
Product summary
- Event
- Event 82011
- Status
- Terminated
- Classification
- Class III
- Quantity
- 49 kits
- Official record key
device-enforcement:Z-1256-2019
Official wording
Reason: Shelf life of the product may be reduced due to degradation of the assay.
Code information: (a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025
Distribution pattern: US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
Derived failure modes
-
Unknown
Shelf life of the product may be reduced due to degradation of the assay.