All Recalls

95,114 total recalls in our database

Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

Sep 14, 2020 Other Medical Devices Nationwide View Details →

Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed

Aug 19, 2020 Diagnostic Equipment Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient

Aug 31, 2020 Other Medical Devices View Details →