Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-0817-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

VITROS Chemistry Products COCM Reagent

Product Classification:

Class II

Date Initiated: October 4, 2013

Date Posted: January 29, 2014

Recall Number: Z-0817-2014

Event ID: 66474

Reason for Recall:

Inaccurate quality control results.

Status: Terminated

Product Quantity: 3,342 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated