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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products COCM Reagent

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 Class 2 Device Recall VITROS Chemistry Products COCM Reagentsee related information
Date Initiated by FirmOctober 04, 2013
Date PostedJanuary 23, 2014
Recall Status1 Terminated 3 on May 17, 2018
Recall NumberZ-0817-2014
Recall Event ID 66474
510(K)NumberK062123 
Product Classification Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
ProductVITROS Chemistry Products COCM Reagent
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
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall		Inaccurate quality control results.
FDA Determined
Cause 2		Other
ActionOn 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 Commerce3,342 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DIO
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