Drug recall
MTS A/B/D Monoclonal and Reverse Grouping Card (Product Code MTS080515)
FDA recall event 64576 · Class II, Class III · Micro Typing Systems, Inc.
Key facts
| Event ID | 64576 |
|---|---|
| Recall numbers | B-1236-13, B-1237-13 |
| Recalling firm | Micro Typing Systems, Inc. |
| Product type | Biologics |
| Products | MTS A/B/D Monoclonal and Reverse Grouping Card (Product Code MTS080515), MTS Anti-IgG Cards (Catalog # MTS 084024) |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. |
| Initiation date | Nov 5, 2012 |
| Report date | Apr 10, 2013 |
| Termination date | Jul 2, 2013 |
| 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: