Recall Z-1253-2019
Carolina Liquid Chemistries · initiated January 16, 2019
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Codes / lots: Lot 11687
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm initiated the recall by email on 01/16/2019. The notice requested that the consignee discard the product.
Details
- Recall number
- Z-1253-2019
- Initiated
- January 16, 2019
- Terminated
- February 2, 2021
- Product code
- DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Quantity
- 20 kits
- Distribution
- NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
- Recalling firm
- Carolina Liquid Chemistries, Greensboro, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1252-2019 Class III | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | 01/16/2019Terminated |