Device recall
Z-2387-2011: DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial…
FDA device recall · Class II · Express Diagnostics Int'l., Inc.
Key facts
| Recall number (Z-number) | Z-2387-2011 |
|---|---|
| Recall event | 58652 |
| Product | DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Earth MN 56013 USA, Model numbers : 70801-4(NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR, Lot 4-801 102910, Exp APR 2012, & Lot 4-801 112210, Exp MAY 2012, Export Only); 65500-4A… |
| Product code | DJG |
| Recalling firm | Express Diagnostics Int'l., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2012 |
| 510(k) numbers | K042975, K050186, K053175, K063015 |
| FEI number | 3014946040 |
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