ClearanceBrief
Recall Z-1252-2019 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Carolina Liquid Chemistries

CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

DateJan 16, 2019
StatusTerminated
Reason
Root causeNonconforming Material/Component
ActionThe firm initiated the recall by email on 01/16/2019. The notice requested that the consignee discard the product.
Quantity14 kits
DistributionNY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K032461ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
Lin-Zhi International, Inc., Oct 3, 2003