Device recall
Z-1373-04: ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48…
FDA device recall · Class III · Remel, Inc.
Key facts
| Recall number (Z-number) | Z-1373-04 |
|---|---|
| Recall event | 29677 |
| Product | ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. |
| Product code | GMZ |
| Recalling firm | Remel, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 15, 2004 |
| 510(k) numbers | K980507 |
| FEI number | 1924669 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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