Drug recall
ORTHO Optix Reader for ORTHO ID-MTS Gel Cards Product Code: 6842222 Unique Device Identifier: 10758750032846
FDA recall event 91151 · Class III · Ortho-Clinical Diagnostics, Inc.
Key facts
| Event ID | 91151 |
|---|---|
| Recall numbers | B-0269-2023 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Product type | Biologics |
| Products | ORTHO Optix Reader for ORTHO ID-MTS Gel Cards Product Code: 6842222 Unique Device Identifier: 10758750032846 |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Ortho Clinical is recalling distributed units of the ORTHO ID-MTS" Gel Cards software because the discrepant result checks may not perform as expected. |
| Initiation date | Nov 9, 2022 |
| Report date | Mar 22, 2023 |
| City | Raritan |
| State | NJ |
| Country | United States |
| FEI number | 2250051 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: