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 of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Reported: September 26, 2012 Initiated: August 7, 2012 #Z-2410-2012
Product Description
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 of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Reason for Recall
ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 15,445 kits
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
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 of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 15,445 kits.
Why was this product recalled? ▼
ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2012. Severity: Low. Recall number: Z-2410-2012.
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