Medical device recalls

Carolina Liquid Chemistries recalls CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

Recall date
January 16, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1253-2019
FDA classification
Class III
Brand / firm
Carolina Liquid Chemistries
Sold / distributed
NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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