Recall Z-1885-2013— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1885-2013
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: K940006. Product: IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). 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

K940006 — IMMULITE THIRD GENERATION (MODIFICATION)Diagnostic Products Corp.·cleared 1994-12-19

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

IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). 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.