Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Reported: September 4, 2024 Initiated: June 17, 2024 #Z-2736-2024
Product Description
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Reason for Recall
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
Details
- Recalling Firm
- Abbott Diagnostics Technologies AS
- Units Affected
- 5 analyzers
- Distribution
- US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
- Location
- Oslo
Frequently Asked Questions
What product was recalled? ▼
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.. Recalled by Abbott Diagnostics Technologies AS. Units affected: 5 analyzers.
Why was this product recalled? ▼
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2024. Severity: Moderate. Recall number: Z-2736-2024.
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