IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3)
FDA Recall Z-1691-2018 · Posted 2018-05-04
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeMOI
Date Initiated2018-01-02
Date Terminated2023-02-10
Reason for Recall
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.
Firm Action
Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
Root Cause
Error in labeling
Distribution Pattern
Nationwide and Canada, Mexico, and Thailand
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.