Drug recall
ORTHO VISION Analyzer for ID-MTS when Processing ORTHO Sera Anti-Jkb Blood Grouping Reagent (Software 5.14.5…
FDA recall event 92654 · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Event ID | 92654 |
|---|---|
| Recall numbers | B-0129-2024, B-0130-2024 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Product type | Biologics |
| Products | ORTHO VISION Analyzer for ID-MTS when Processing ORTHO Sera Anti-Jkb Blood Grouping Reagent (Software 5.14.5 and below), Product Codes 6904577, 6904549, ORTHO VISION Max Analyzer for ID-MTS when Processing ORTHO Sera Anti-Jkb Blood Grouping Reagent (Software 5.14.5 and below), Product Codes 6904576, 6904549 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Ortho Clinical Diagnostics is recalling the ORTHO VISION and ORTHO VISION Max Analyzers for ID-Micro Typing System (MTS) Gel Cards when using the ORTHO Sera Anti-Jk Blood Grouping Reagent for the… |
| Initiation date | Jun 27, 2023 |
| Report date | Feb 7, 2024 |
| 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: