Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1253-2019 — CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

U.S. FDA — Device Enforcement · United States · 2019-01-16 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1253-2019
Date of alert
2019-01-16
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Carolina Liquid Chemistries
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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