FDA recall Z-1253-2019

Product

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-01-16

Report date

2019-05-08

Termination date

2021-02-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1253-2019