Device recall
Z-1053-04: Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130…
FDA device recall · Class I · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1053-04 |
|---|---|
| Recall event | 29394 |
| Product | Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK. |
| Product code | MMI |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 18, 2005 |
| 510(k) numbers | K031031 |
| FEI number | 1000136573 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database