StreamLab Analytical Workcell. General Purpose Laboratory Device.
FDA device recall Z-0373-05 · posted 2004-12-28 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 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.
- Date initiated
- 2004-11-12
- Date posted
- 2004-12-28
- Date terminated
- 2005-03-28
- Location
- Newark, DE
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