ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
FDA Recall Z-1512-2013 · Posted 2013-06-06
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Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeCEW
Date Initiated2013-05-14
Date Terminated2015-03-05
Product Quantity309 (100 test) kits
Reason for Recall
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Firm Action
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.
Root Cause
No Marketing Application
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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