Recalls / —

—#162522

Product

ADVIA Centaur Cyclosporine

FDA product code

MKW — Cyclosporine

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K071455

Affected lot / code info

ADVIA Centaur¿ Cyclosporine; Cyclosporine; SMN 10335448  Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031

Why it was recalled

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere

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 #162522. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.