ADVIA Centaur iPTH Calibrator 2 pk recall
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Why was ADVIA Centaur iPTH Calibrator 2 pk 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?
Calibrator Lot Number: C5601 and C5602 Kit Lot Number/Exp. Date: 61405A01 27 Oct 2011 66517A02 27 Oct 2011 66611A02 27 Oct 2011 71997C02 27 Oct 2011
- Product
- ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 99 (2 pk)
- Distribution
- Nationwide Distribution.
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)