medical Class II Updated 2018-05-16

Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent car

Recalled Product

Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge

Hazard / Issue

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: CTNI, immunoassay method, troponin subunit, K6421, SMN# 10445098 Lot codes: 16336BA 16347BD 16363BC 17032AD 17045BC 17054BD 17074BC 17093BD 17121BA 17145BE 17180BB 17193BD 17201BB 17223BA 17264BC
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