Device recall
Z-1320-2013: QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is…
FDA device recall · Class II · QIAGEN Gaithersburg, Inc.
Key facts
| Recall number (Z-number) | Z-1320-2013 |
|---|---|
| Recall event | 64650 |
| Product | QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook. |
| Product code | LKQ |
| Recalling firm | QIAGEN Gaithersburg, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 1, 2013 |
| FEI number | 3003572099 |
At a glance
- None 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