Warning Letter Close-Outs – August 2021
The US FDA issued three device-related close-out letters in August.
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Several additional batches of Magellan’s LeadCare II tests are being recalled as efforts to address the root cause continue.
The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.
The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.