FDA-Device2019-05-08Class III
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Carolina Liquid Chemistries
Hazard
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.
Sold states
NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ
Affected count
20 kits
Manufactured in
313 Gallimore Dairy Rd, N/A, Greensboro, NC, United States
Products
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1253-2019Don't want to check this manually?
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