Recalls / —

—#122450

Product

VITROS Chemistry Products COCM Reagent

FDA product code

DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device class

Class 2

Medical specialty

Clinical Toxicology

510(k) numbers

K062123

Affected lot / code info

Product Code: 6801995; Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013, 2) 1525-10-2091 Exp Date: 1 March 2014, 3) 1525-10-3062; Exp Date: 1 April 2014

Why it was recalled

Inaccurate quality control results.

Root cause (FDA determination)

Other

Action the firm took

On October 4, 2013 Ortho Clinical Diagnostics issued a Product Correction Notification to customers via US Postal Service Priority Mail or FedEx regarding VITROS Chemistry Products COCM Reagent due to inaccurate quality control results. Ortho Clinical Diagnostics advised their customers to discontinue use and discard any recalled product. OCD customers with questions should be contact Customer Technical Services at 1-800-421-3311.

Recalling firm

Firm

Ortho-Clinical Diagnostics

Address

100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2013-10-04

Posted by FDA

2014-01-23

Terminated

2018-05-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #122450. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.