FDAClass IIJune 7, 2017

Herpes Simplex Virus I recall

Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Why was Herpes Simplex Virus I recalled?

Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.

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?

7.0 ml lot 1432301A, expiry 2017-10; lot 1525206A , expiry 201 8-08.

Product
Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Recalling firm
Cell Marque Corporation
Quantity
3
Distribution
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Recall date
June 7, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls