RecallRadar

FDA Device recall Z-1253-2019

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

On 2019-05-08 the FDA classified a Class III recall of CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 by Carolina Liquid Chemistries, citing 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 e….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1253-2019
ClassificationClass III
Statusterminated
Initiated2019-01-16
Published2019-05-08
Last updated2026-09-13 11:55 UTC
CompanyCarolina Liquid Chemistries
DistributionAR, CA, CT, IL, ME, NC, NH, NJ, NY, SC, TX

Product

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

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.

Identifiers

code_infoLot 11687

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2019%22

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