—#118314

Product

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

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K020217
Affected lot / code info: Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 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 #118314. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.