Recall Z-1513-2013— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1513-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-14

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2013-05-14, terminated 2015-03-05. It names one FDA 510(k) clearance: K121981. 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).. Reason: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability.

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-14
Terminated: 2015-03-05
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAYSiemens Healthcare Diagnostics·cleared 2013-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.