ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests recall
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of…
Why was ADVIA Centaur¿ iPTH ReadyPack Assay 500 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 Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011
- Product
- ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 3302 Kits (500 test)
- Distribution
- Nationwide Distribution.
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)