Z-1253-2019Class III

Carolina(r) Liquid Chemistries Corp. Etha Rgt. Kit, IVD, Ref St321

Name: Z-1253-2019 Carolina(r) Liquid Chemistries Corp. Etha Rgt. Kit, IVD, Ref St321
Creator: Carolina Liquid Chemistries
Published: 2019-01-16
License: https://open.fda.gov/license/

Carolina Liquid Chemistries / initiated 2019-01-16 / Terminated / root cause: manufacturing process

FDA source

Carolina Liquid Chemistries began a recall of CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 on 2019-01-16. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1253-2019
Classification: Class III
Status: Terminated
Initiated: 2019-01-16
Posted: 2019-05-02
Terminated: 2021-02-02
Recalling firm: Carolina Liquid Chemistries
Product: Carolina(r) Liquid Chemistries Corp. Etha Rgt. Kit, IVD, Ref St321
Product code: DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall by email on 01/16/2019. The notice requested that the consignee discard the product.
Quantity in commerce: 20 kits
Distribution: NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
Product codes and lots: Lot 11687

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1253-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1252-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1253-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02

Product code DIC

K032461Class IIEthyl Alcohol Enzymatic Assay, Catalog #0220 & 0221Lin-Zhi International, Inc. / cleared 2003-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)