FDAClass IINovember 5, 2014

ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA recall

ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog…

Why was ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: 82052A22 Exp Date 01/19/2013 82335A22 82909A22 85268A22 86701B22 88921B22 89956B22 90925B22 91336B22 95231A23 Exp. Date: 01/16/2013 95553A23

Product
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog…
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
8263 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.
Recall date
November 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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