—#118312

Product

ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).

FDA product code: CEW — Radioimmunoassay, Parathyroid Hormone
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K121981
Affected lot / code info: Reagent Lot Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011

Why it was recalled

iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Root cause (FDA determination)

No Marketing Application

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2013-05-14
Posted by FDA: 2013-06-06
Terminated: 2015-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118312. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.