Recall Z-1512-2013

Siemens Healthcare Diagnostics, Inc · initiated May 14, 2013

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 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-1512-2013
Initiated
May 14, 2013
Posted by FDA
June 6, 2013
Terminated
March 5, 2015
Product code
CEW – Radioimmunoassay, Parathyroid Hormone
Quantity
309 (100 test) kits
Distribution
Nationwide Distribution.
Recalling firm
Siemens Healthcare Diagnostics, Inc, East Walpole, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1513-2013 Class IIADVIA 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-1514-2013 Class IIADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in…iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability 05/14/2013Terminated
Z-1515-2013 Class IIADVIA 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