Siemens BCS XP Analyzer Recalled for False Clotting Results
Siemens Healthcare Diagnostics is recalling BCS XP Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low INR values for specific patient samples.
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 medical device that may produce inaccurate diagnostic results (false short clotting times and low INR), which poses a risk of harm to patients through potential misdiagnosis or inappropriate treatment, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the BCS XP Automated Blood Coagulation Analyzer System. The recall affects 1,895 units distributed worldwide, including the United States and numerous international markets. The affected catalog numbers are 10459330, 10462449, 10461894, and 10470625.
The recall is due to the potential for false short clotting times for Prothrombin Time (PT) when using Dade Innovin reagent. This issue can also result in false low PT INR values. The error occurs specifically with turbid, hemolytic, and/or icteric samples from intensive care patients. The reaction curves for these samples show a pre-peak that leads to the falsely short clotting time, a result that is not flagged by the device's existing check algorithms.
Healthcare facilities and laboratories using these systems should contact Siemens Healthcare Diagnostics for instructions on how to address the issue. The source text does not specify a deadline or additional consumer actions beyond the standard recall procedures.
The recalled product
- Product
- BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,895
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)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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