Beckman Coulter
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Beckman Coulter and translate it into plain English — free weekly digest, optional same-day alerts.
- 2012-10-10FDA-DeviceClass IIStop using Beckman Coulter RF reagent lots M012376, M101865
The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results.
- 2012-10-10FDA-DeviceClass IICOULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent.
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