Z-0817-2014Class II

VITROS Chemistry Products COCM Reagent

Name: Z-0817-2014 VITROS Chemistry Products COCM Reagent
Creator: Ortho-Clinical Diagnostics
Published: 2013-10-04
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-10-04 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products COCM Reagent on 2013-10-04. FDA classified it as Class II and gives the reason as "Inaccurate quality control results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0817-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-04
Posted: 2014-01-23
Terminated: 2018-05-17
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products COCM Reagent
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Reason for recall: Inaccurate quality control results.
FDA root cause: Other
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0817-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0817-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code DIO

K062123Class IIVitros Chemistry Products Cocm Reagent, Calibrator Kit 26, Fs Calibrator 1 and Dat Performance Verifiers I, II, III, IVOrtho-Clinical Diagnostics, Inc. / cleared 2006-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)