Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 2,908 recalls
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain sympt…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.