Recall Z-0373-05 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Dade Behring , Inc.
StreamLab Analytical Workcell. General Purpose Laboratory Device.
| Date | Dec 28, 2004 (initiated Nov 12, 2004) |
| Status | Terminated |
| Reason | Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems. |
| Root cause | Other |
| Action | The recalling firm issued letters dated 11/12/04 to their customers informing them of the problem. The letter also states that a sales representative will contact them to make arrangements for an upgrade. |
| Quantity | 15 units |
| Distribution | The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.