FDAClass IIIMay 8, 2019

Ethyl Alcohol Enzymatic Assay recall: Impurity Out of Spec

Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH…

Why was Ethyl Alcohol Enzymatic Assay recalled?

Shelf life of the product may be reduced due to degradation of the assay.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

(a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025

Product
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH…
Recalling firm
Lin-Zhi International Inc
Quantity
49 kits
Distribution
US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
Recall date
May 8, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls