Device recall
Z-1330-2013: Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is…
FDA device recall · Class III · Bio-rad Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1330-2013 |
|---|---|
| Recall event | 64959 |
| Product | Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor… |
| Product code | JJY |
| Recalling firm | Bio-rad Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 1, 2013 |
| 510(k) numbers | K040822 |
| FEI number | 2016706 |
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