Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Reported: October 9, 2024 Initiated: August 21, 2024 #Z-3305-2024
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 9783 kits
- Distribution
- Worldwide distribution - US Nationwide.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test). Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 9783 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2024. Severity: Moderate. Recall number: Z-3305-2024.
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