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Terminated

ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.

FDA Recall Z-1515-2013 · Posted 2013-06-06

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeJIT
Date Initiated2013-05-14
Date Terminated2015-03-05
Product Quantity198 (6 pk)

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.

K020217ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAYBayer Diagnostics Corp. · 2002-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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