Recall Z-0817-2014 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Ortho-Clinical Diagnostics
VITROS Chemistry Products COCM Reagent
| Date | Jan 23, 2014 (initiated Oct 4, 2013) |
| Status | Terminated |
| Reason | Inaccurate quality control results. |
| 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 | 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, Ital |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062123 | VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV Ortho-Clinical Diagnostics, Inc., Nov 16, 2006 |