Device product
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Z-1253-2019
Product summary
- Event
- Event 82017
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20 kits
- Official record key
device-enforcement:Z-1253-2019
Official wording
Reason: Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.
Code information: Lot 11687
Distribution pattern: NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
Derived failure modes
-
Unknown
Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.