Ortho-Clinical Diagnostics, Inc. Recall 93632
Description: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Ortho-Clinical Diagnostics, Inc. Recall 93632 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0772-2024 |
| Event ID | 93632 |
| Event Description | VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands. |
| Quantity | 6,920 US; 57 OUS |
| Recall Reason | Affected lots may experience increased calibration failures or an increase in falsely elevated results. |
| Device Classification | 20240131 |
| Device Code Info | UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990 |
| Center Classification Date | 20240119 |
| Recall Initiation Date | 20231127 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc. |
| Initial Notification | Letter |
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