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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65162
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc
City East Walpole
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. 172913 Z-1881-2013
Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. 39763 Z-1882-2013
Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. 33506 Z-1883-2013
Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. 18584 Z-1884-2013
IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. 51792 Z-1885-2013
IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. 13462 Z-1886-2013
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