Recall Z-1253-2019— Carolina Liquid Chemistries

Name: FDA recall Z-1253-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-16

Class III · Terminated

Class III FDA medical device recall by Carolina Liquid Chemistries, initiated 2019-01-16, terminated 2021-02-02. It names one FDA 510(k) clearance: K032461. 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..

Recalling firm: Carolina Liquid Chemistries
Classification: Class III
Status: Terminated
Initiated: 2019-01-16
Terminated: 2021-02-02
Firm location: Greensboro, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K032461 — ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221Lin-Zhi International, Inc.·cleared 2003-10-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.