StreamLab Analytical Workcell. General Purpose Laboratory Device.
This recall has been terminated (originally issued December 28, 2004).
- Recall Initiated
- November 12, 2004
- Posted
- December 28, 2004
- Terminated
- March 28, 2005
- Recall Number
- Z-0373-05
- Quantity
- 15 units
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
Distribution
The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.
Lot / Code Info
Software version 3.5
Root Cause
Other
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.
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