Siemens BCS Behring Coagulation System Recalled for Potential Test Errors
Siemens Healthcare Diagnostics is recalling 186 BCS Behring Coagulation Systems because a specific sequence of tests may result in shortened clotting times.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is inaccurate test results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 186 units of the BCS(R) Behring Coagulation System, Device catalog No. OVIO03. This multipurpose system is used for in vitro coagulation studies. The recall is not lot-specific.
The firm confirmed that if the Cleaner SCS vial becomes empty after processing a test for the Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the immediately following test is an APTT based clotting assay, several results may be shortened. This issue could lead to inaccurate diagnostic results.
The affected devices were distributed worldwide, including nationwide in the United States and in various countries in Europe, the Middle East, and Australia. Users should contact Siemens Healthcare Diagnostics for further instructions on how to address this issue.
The recalled product
- Product
- BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 186
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Device catalog No. OVIO03 (not lot specific)
Distribution
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