Siemens ADVIA Centaur FSH Calibrator B Recalled for Analytical Sensitivity Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur FSH Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a failure to meet stated analytical sensitivity, which is a performance defect rather than a direct physical hazard like contamination or injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 15,445 kits of the ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B. The recall covers specific lot numbers and expiration dates for both US and international markets. The product is used for in vitro diagnostic testing to determine follicle-stimulating hormone (FSH) levels in serum.
The recall was initiated because the Calibrator B fails the analytical sensitivity stated in the instructions for use (IFU) for lots below 40. This defect may affect the accuracy of the diagnostic results obtained using the affected calibrators.
The affected products were distributed worldwide, including the United States, Canada, and numerous countries in Asia, Europe, South America, and Africa. Users of the ADVIA Centaur and ADVIA Centaur XP systems should check their inventory for the specific lot numbers and reference codes listed in the official recall notice. Siemens Healthcare Diagnostics is managing the recall and will contact customers to arrange for the return or replacement of the affected units.
The recalled product
- Product
- ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 15,445
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 (3)
- US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2
- 8
- 2102 79197A29 83314C29
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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