—#162523

Product

ADVIA Centaur DHEA-SO4

FDA product code: JKC — Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: ADVIA Centaur¿ DHEA-SO4; radioimmunoassay, dehydroepiandrosterone (free and sulfate); SMN 10282227 ADVIA Centaur DHEA-S Kit Lot # 00119053 14041053 80449053 90520053 29750054 30423054 39155054 50533054 63267055 68936055 79273055 86427055 06402057 07109057 14187057 37499057

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 #162523. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.