Siemens BCS Blood Coagulation Analyzer Recall for False Results
Siemens is recalling BCS Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low PT INR values when testing specific types of 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 is classified as FDA Class II. The hazard involves a risk of harm (incorrect diagnostic results) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,680 units of the BCS Automated Blood Coagulation Analyzer System. The affected devices are used for in vitro coagulation studies and were distributed worldwide, including in the United States and numerous international markets. The recall covers specific catalog numbers, including 10454728, 10454729, 10454742, 10459303, 10460659, and 10461881.
The recall was initiated because the devices may produce false short clotting times for Prothrombin Time (PT) tests when used with Dade Innovin reagent. This issue specifically affects turbid, hemolytic, and/or icteric samples from intensive care patients. The reaction curves for these samples show a pre-peak that the device's existing check algorithms do not flag, leading to falsely short clotting times and consequently false low PT INR values.
Healthcare facilities and laboratories using these devices should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to address the issue. The source text does not specify a specific action for consumers, as these are professional medical devices.
The recalled product
- Product
- BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 1046
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,680
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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