Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 34 recalls
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectl…
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration da…
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration da…
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration da…
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed.…
Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of fals…
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…
Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibrat…
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose co…
Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.