Recall Z-3305-2024— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-3305-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-21

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2024-08-21. It names one FDA 510(k) clearance: K003291. Product: Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test). Reason: Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-21
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K003291 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAYBayer Diagnostics Corp.·cleared 2000-12-05

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

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

Reason for recall

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

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