Beckman Coulter, Inc.: Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Num

Hazard

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

Details from the source

Reason for recall: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results. Distribution: US Nationwide. Global Distribution. Quantity: 38,225 untis Lot/code info: UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005

UPC codes

15099590180249

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.