Recall Z-2054-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2054-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-18

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-12-18. It names one FDA 510(k) clearance: K150403. Product: ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests). Reason: In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2017-12-18
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K150403 — ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc.·cleared 2015-05-01

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

ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)

Reason for recall

In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.

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