Device product

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)

Z-1691-2018

January 02, 2018

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 79505
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-1691-2018

Official wording

Reason: 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.

Code information: BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2) CA15-3(BR-MA) Lot # 265 266 267

Distribution pattern: Nationwide and Canada, Mexico, and Thailand

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.