FDAClass IIINovember 13, 2013

ADVIA Centaur Intact PTH Calibrator recall

ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA…

Why was ADVIA Centaur Intact PTH Calibrator recalled?

PTH Calibrator packaged with only high calibrator.

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?

Kit Lot: 14136A16 04 Mar 2014

Product
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA…
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
595 kits total (5 kits with packaging error)
Distribution
Nationwide Distribution including MD, PA, and CT.
Recall date
November 13, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls