FDA Medical devices recall ·
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887… recall
- Recall number
- Z-3304-2024
- Date
- (initiated August 21, 2024)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave, Tarrytown, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5622 kits
- Hazard tags
- Laceration
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337
Distribution
Worldwide distribution - US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3304-2024. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.