ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
Reported: November 5, 2014 Initiated: October 9, 2012 #Z-0129-2015
Product Description
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
Reason for Recall
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 2440 kits
- Distribution
- Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack). Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 2440 kits.
Why was this product recalled? ▼
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2014. Severity: Moderate. Recall number: Z-0129-2015.
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