Drug recall
ORTHO-ProVue (TM) A modular, microprocessor-controled instrument.
FDA recall event 32594 · Class II · Micro Typing Systems Inc.
Key facts
| Event ID | 32594 |
|---|---|
| Recall numbers | B-2373-12 |
| Recalling firm | Micro Typing Systems Inc. |
| Product type | Biologics |
| Products | ORTHO-ProVue (TM) A modular, microprocessor-controled instrument. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | ORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed. |
| Initiation date | Jul 8, 2004 |
| Report date | Aug 8, 2012 |
| Termination date | Aug 17, 2012 |
| City | Pompano Beach |
| State | FL |
| Country | United States |
| FEI number | 1000132079 |
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: