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Terminated

VITROS Chemistry Products COCM Reagent

FDA Recall Z-0817-2014 · Posted 2014-01-23

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeDIO
Date Initiated2013-10-04
Date Terminated2018-05-17
Product Quantity3,342 units

Reason for Recall

Inaccurate quality control results.

Firm 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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062123VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IVOrtho-Clinical Diagnostics, Inc. · 2006-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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