IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Reported: August 14, 2013 Initiated: May 10, 2013 #Z-1885-2013
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 51792
- 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? ▼
IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 51792.
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-1885-2013.
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