Device recall
Z-1089-2009: Sm ELISA Test System Product number 2Z2831G and Product number 43270CE…
FDA device recall · Class II · Zeus Scientific Inc
Key facts
| Recall number (Z-number) | Z-1089-2009 |
|---|---|
| Recall event | 49438 |
| Product | Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. Also manufactured for Wampole Laboratories, Princeton, NJ 08540… |
| Product code | LJM |
| Recalling firm | Zeus Scientific Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2009 |
| 510(k) numbers | K941409 |
| FEI number | 2242436 |
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