ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 te...
FDA Recall #Z-2054-2018 — Class II — December 18, 2017
Product Description
ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
Reason for Recall
In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
74,215
Distribution
Distributed in the following U.S. states: AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, RI, TN, TX, VA, WA, WV, WY and Puerto Rico. Distributed in the following OUS countries: Australia Belgium¿¿¿¿¿¿¿¿ Canada Chile France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Israel Italy¿¿¿¿¿¿¿¿¿¿ Japan Latvia¿¿¿¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Netherlands¿¿¿¿ New Zealand Norway¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿
Code Information
Lot Numbers ending in: 298 and 301
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated