Device recall
Z-0216-2009: Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0216-2009 |
|---|---|
| Recall event | 49427 |
| Product | Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity… |
| Product code | JJX |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 18, 2010 |
| 510(k) numbers | K984323 |
| FEI number | 1415939 |
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