FDAClass IIJune 12, 2013

ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests recall

ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid…

Why was ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests recalled?

iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

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?

Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011

Product
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid…
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
309 (100 test) kits
Distribution
Nationwide Distribution.
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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