DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
This recall has been terminated (originally issued October 23, 2004).
- Recall Initiated
- August 27, 2004
- Posted
- October 23, 2004
- Terminated
- May 10, 2005
- Recall Number
- Z-0042-05
- Quantity
- 7140 units
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
APTT determinations when using affected rotors may lead to incorrectly shortened times
Distribution
The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
Lot / Code Info
Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
Root Cause
Other
Action Taken
The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established.
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