FDA-Device2025-12-17Class IIPROCESSING DEFECT

Beckman Coulter Access 2 Reaction Vessels recalled for manufacturing defects causing instrument errors

OTHERNationwide distribution

Stop using affected Beckman Coulter reaction vessels

Certain lots of Beckman Coulter Access 2 Reaction Vessels contain small defects on the bottom that may cause errors in laboratory immunoassay instruments. These defects could delay patient test results. The recall affects specific lot numbers distributed nationwide and globally.

  • Check if your Access 2 Immunoassay system uses reaction vessels from lots P243943, P243971, P244202, P244344, P244345, P250001–P250005
  • Stop using affected vessels immediately
  • Contact Beckman Coulter or your supplier for replacement or instructions
  • Review any patient results processed with affected lots for potential delays or errors
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.

Sold states
US Nationwide. Global Distribution.
Affected count
38,225 untis
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0889-2026

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