Recall Z-1514-2013
Siemens Healthcare Diagnostics, Inc · initiated May 14, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Codes / lots: 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
Reason for recall
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
FDA-determined cause: No Marketing Application
Action taken
Siemens sent an Urgent Medical Device Correction letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions, contact your Siemens Technical Solutions Center or your local Siemens technical support.
Details
- Recall number
- Z-1514-2013
- Initiated
- May 14, 2013
- Posted by FDA
- June 6, 2013
- Terminated
- March 5, 2015
- Product code
- JIT – Calibrator, Secondary
- Quantity
- 99 (2 pk)
- Distribution
- Nationwide Distribution.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1512-2013 Class II | ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use…iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | 05/14/2013Terminated |
| Z-1513-2013 Class II | ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in…iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | 05/14/2013Terminated |
| Z-1515-2013 Class II | ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use…iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | 05/14/2013Terminated |