Recall Z-1883-2013— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1883-2013
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: K081074. Product: Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). 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

K081074 — DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691Siemens Healthcare Diagnostics, Inc.·cleared 2008-05-23

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

Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). 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.