Recalls / —

—#162520

Product

IMMULITE 2000/IMMULITE 2000 XPi TG

FDA product code

MSW — System, Test, Thyroglobulin

Device class

Class 2

Medical specialty

Immunology

510(k) numbers

K982468

Affected lot / code info

TG, TG (IMMULITE/IMMULITE 1000, LKTY1(D)), (IMMULITE 2000/IMMULITE 2000 XPi, LKTY2(D))  Lot codes: TG Lot # 346 347 348 349 350 351 352 353 354 355 356 D348 D349 D350 D351 D352 D353 D354 D356

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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

Recalling firm

Firm

Siemens Healthcare Diagnostics, Inc.

Address

511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern

Nationwide and Canada, Mexico, and Thailand

Timeline

Recall initiated

2018-01-02

Posted by FDA

2018-05-04

Terminated

2023-02-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #162520. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.