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Terminated

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

FDA Recall Z-1253-2019 · Posted None

Recalling FirmCarolina Liquid Chemistries
Recall StatusTerminated
Product CodeDIC
Date Initiated2019-01-16
Date Terminated2021-02-02
Product Quantity20 kits

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.

Firm Action

The firm initiated the recall by email on 01/16/2019. The notice requested that the consignee discard the product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032461ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221Lin-Zhi International, Inc. · 2003-10-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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