Siemens BCS XP System Recalled for Potential Emicizumab Carryover
Siemens Healthcare Diagnostics is recalling BCS XP Systems due to a potential risk of Emicizumab carryover on patient samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 injury has not yet been reported, fitting the 'High' severity criteria for potential diagnostic errors without confirmed adverse events.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the BCS XP System, a multipurpose instrument intended to perform quantitative assays of specific parameters in plasma. The recall involves 1,547 assays distributed worldwide, including nationwide distribution in the United States and in numerous international countries.
The recall was initiated because Siemens Healthcare Diagnostics Products GmbH confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. This issue could impact the accuracy of in vitro coagulation studies performed using the affected equipment.
Healthcare facilities and laboratories that have received or are using the BCS XP System should contact Siemens Healthcare Diagnostics for further instructions regarding the recall and potential replacement or repair of the affected units.
The recalled product
- Product
- BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,547
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)
- (UDI) 00630414945514
Distribution
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