Recall Z-1253-2019 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Carolina Liquid Chemistries
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
| Date | Jan 16, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall by email on 01/16/2019. The notice requested that the consignee discard the product. |
| Quantity | 20 kits |
| Distribution | NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 Lin-Zhi International, Inc., Oct 3, 2003 |