Recall Z-1686-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1686-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-02

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-01-02, terminated 2023-02-10. It names one FDA 510(k) clearance: K971177. Product: IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12. 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-02
Terminated: 2023-02-10
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K971177 — IMMULITE VITAMIN B12 (LKVB1,LKVB5)Diagnostic Products Corp.·cleared 1997-05-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.