Reported Apr 28, 2021 · Terminated
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 -…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- BCS XP SystemMultipurpose system for in vitro coagulation studies
- Product code
104593301046189410470625 -
- Product UsageThe Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma
- Lot codes and dates
- (UDI) 00630414945514
- Amount recalled
- 1547 assays
Where it was sold
Why it was recalled
Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
This product could cause temporary or reversible health problems — stop using it.
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