Siemens Homocysteine Calibrator Recall Due to Accuracy Issues
Siemens Healthcare Diagnostics is recalling certain lots of homocysteine calibrators that may provide inaccurate test results due to calibrator instability.
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: This is a risk-of-harm medical device where the hazard (inaccurate calibration leading to incorrect patient test results) is present but no illnesses or injuries have been reported. The FDA Class II classification supports a High severity rating.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling certain lots of ADVIA Centaur HCY Calibrators (material number 10310376) due to calibrator instability. The recalled calibrators do not meet the assay instructions and reference intervals, resulting in increased positive bias that can lead to inaccurate test results.
The recall affects 1,072 packs (2,144 units total) with specific lot numbers 86237A74 and 44207A75. The affected calibrators were distributed worldwide, including throughout the United States, and in multiple international markets.
Healthcare facilities using these calibrators should stop use immediately and contact Siemens Healthcare Diagnostics for instructions on obtaining replacement calibrators. Affected customers should verify whether they have received any of the recalled lots and discontinue their use to ensure accurate patient test results.
The recalled product
- Product
- ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- calibrator-instability
- measurement-bias
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 (2)
- (01)00630414468198(10)44207A75(17)20250925. Kit lot numbers: 86237A74
- 44207A75.
Distribution
Distributed nationwide across the United States.
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