FDA Devices Moderate Class II Terminated

Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

Reported: August 14, 2013 Initiated: May 10, 2013 #Z-1883-2013

Product Description

Reason for Recall

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

Details

Recalling Firm: Siemens Healthcare Diagnostics, Inc
Units Affected: 33506
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.
Location: East Walpole, MA

Frequently Asked Questions

What product was recalled? ▼

Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 33506.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 14, 2013. Severity: Moderate. Recall number: Z-1883-2013.