Siemens Healthcare Diagnostics, Inc. recalls Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
- Recall date
- August 21, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3305-2024
- FDA classification
- Class II
- Brand / firm
- Siemens Healthcare Diagnostics, Inc.
- Sold / distributed
- Worldwide distribution - US Nationwide.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Get recall alerts
Free email alert whenever Siemens Healthcare Diagnostics, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Siemens Healthcare Diagnostics, Inc.