PlainRecalls
FDA Devices Moderate Class II Terminated

VITROS Chemistry Products COCM Reagent

Reported: January 29, 2014 Initiated: October 4, 2013 #Z-0817-2014

Product Description

VITROS Chemistry Products COCM Reagent

Reason for Recall

Inaccurate quality control results.

Details

Units Affected
3,342 units
Distribution
Worldwide Distribution. US nationwide (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico), Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
Location
Rochester, NY

Frequently Asked Questions

What product was recalled?
VITROS Chemistry Products COCM Reagent. Recalled by Ortho-Clinical Diagnostics. Units affected: 3,342 units.
Why was this product recalled?
Inaccurate quality control results.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 29, 2014. Severity: Moderate. Recall number: Z-0817-2014.