Recall Z-1881-2013— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1881-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-10

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2013-05-10, terminated 2016-05-10. It names one FDA 510(k) clearance: K083844. Product: ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).. Reason: A rare variant of TSH, identified in a small cluster of patients, is not detected..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-10
Terminated: 2016-05-10
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K083844 — ADVIA CENTAUR TSH3-ULTRA METHODSiemens Healthcare Diagnostics·cleared 2009-05-08

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 Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Reason for recall

A rare variant of TSH, identified in a small cluster of patients, is not detected.

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