Ortho-Clinical Diagnostics, Inc. Recall 89183
Description: VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Ortho-Clinical Diagnostics, Inc. Recall 89183 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0503-2022 |
| Event ID | 89183 |
| Event Description | VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands. |
| Quantity | 1416 units |
| Recall Reason | Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190. |
| Device Classification | 20220126 |
| Device Code Info | Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898) |
| Center Classification Date | 20220118 |
| Recall Initiation Date | 20211122 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc. |
| Initial Notification | Letter |
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