ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
FDA Recall Z-0173-2014 · Posted 2013-11-06
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Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeCEW
Date Initiated2013-08-16
Date Terminated2014-02-13
Product Quantity595 kits total (5 kits with packaging error)
Reason for Recall
PTH Calibrator packaged with only high calibrator.
Firm Action
Packaging error was brought to Siemens' attention through escalations received from (3) customers in the United States. Internal Investigation confirmed the issue was limited to the five (5) kits distributed to these customers. As the customers were aware of the issue and non affected product was provided to the customers to use during Siemens' investigation, no further communication was warranted.
Root Cause
Packaging
Distribution Pattern
Nationwide Distribution including MD, PA, and CT.
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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