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Abbott Diagnostics Technologies AS
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Abbott Diagnostics Technologies AS and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-09-04FDA-DeviceClass IIAfinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
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.
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