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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension TSH Flex Reagent Cartridge

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 Class 2 Recall
Dimension TSH Flex Reagent Cartridge
see related information
Date Posted August 06, 2013
Recall Status1 Open
Recall Number Z-1882-2013
Recall Event ID 65162
Premarket Notification
510(K) Number
K081074 
Product Classification Radioimmunoassay, Thyroid-Stimulating Hormone - Product Code JLW
Product Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Code Information Per recall strategy.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole, Massachusetts 02032-1516
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
A rare variant of TSH, identified in a small cluster of patients, is not detected.
FDA Determined
Cause 2
DESIGN: Device Design
Action On May 10, 2013, an Important Safety Information notice was sent to all affected Siemens Healthcare Diagnostic customers in the United States. On May 10, 2013, an Urgent Field Safety Notice was sent to all customers outside of the United States. These notices inform the customer that there is a rare variant of TSH, identified in a small cluster of patients that is not detected by some Siemens assays. This notice informs customers that they should continue to use the affected TSH assays as the observed rate of occurrence during a 30-month time period was 0.6 X 10 -7 and there are strong mitigating factors. These mitigating factors include co-interpretation of TSH results in conjunction with thyroxine and TS, patient history and clinical signs and symptoms. Although Siemens believes a look back is not required as the expected frequency of the variant is extremely rare, these notices state that this decision should be made by the medical director.
Quantity in Commerce 39763
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JLW and Original Applicant = Siemens Healthcare Diagnostics Inc.
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