Device recall
Z-0197-05: Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay…
FDA device recall · Class III · Tosoh Bioscience, Inc.
Key facts
| Recall number (Z-number) | Z-0197-05 |
|---|---|
| Recall event | 30182 |
| Product | Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured by TOSOH CORPORATION, TOKYO, JAPAN |
| Product code | NIG |
| Recalling firm | Tosoh Bioscience, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 10, 2004 |
| FEI number | 1000123732 |
At a glance
- None 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