Dade Behring Inc. Rte 896, Glasgow Business Community DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Brand
Dade Behring Inc. Rte 896, Glasgow Business Community
Lot Codes / Batch Numbers
Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
Products Sold
Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
Dade Behring Inc. Rte 896, Glasgow Business Community is recalling DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies due to APTT determinations when using affected rotors may lead to incorrectly shortened times. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
APTT determinations when using affected rotors may lead to incorrectly shortened times
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026