Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 781–792 of 1,125 recalls
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution;…
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.