Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 229–240 of 426 recalls
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanne…
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2.…
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2.…