Z-1256-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- January 11, 2019
- Termination Date
- March 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 kits
Product Description
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.
Reason for Recall
Shelf life of the product may be reduced due to degradation of the assay.
Distribution Pattern
US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
Code Information
(a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025