—#118311

Product

ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. 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 Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 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 #118311. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.