Recalls / —

—#118313

Product

ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. 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 Number: C5601 and C5602 Kit Lot Number/Exp. Date: 61405A01 27 Oct 2011 66517A02 27 Oct 2011 66611A02 27 Oct 2011 71997C02 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 #118313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.