Microbiologics recalled LYFO DISK, Catalog Number 0325L, on December 2, 2025, after reports indicated affected units may fail to recover Campylobacter jejuni. This recall affects one unit, with an additional 16 units added on December 22, 2025. The recall impacts products distributed worldwide, including the United States.
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Microbiologics Inc or your healthcare provider for instructions. Notification method: Letter
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The affected product is LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L. The recall includes Lot Numbers 325-120-5, 325-119-3, and 325-119-6. The product is distributed worldwide.
Affected units may fail to recover the target microorganism, which could lead to incorrect testing results. This poses a high risk for patients relying on accurate microbial identification for diagnosis and treatment.
No specific incidents or injuries have been reported as a direct result of this recall. The potential for incorrect test results poses a significant health risk.
Stop using the affected device immediately. Follow the recall instructions provided by Microbiologics and contact your healthcare provider for further guidance.
For further assistance, contact Microbiologics at their official website or through the notification letter sent to affected parties.
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