Z-1253-2019 Class III Terminated
FDA device recall Z-1253-2019 was initiated by Carolina Liquid Chemistries on January 16, 2019 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated February 2, 2021). Affected quantity: 20 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- January 16, 2019
- Termination Date
- February 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 kits
Product Description
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Reason for Recall
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.
Distribution Pattern
NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
Code Information
Lot 11687