HIGH

Beckman Coulter Recalls Access 2 Reaction Vessels Over Manufacturing Defects

Beckman Coulter recalled 38,225 Access 2 Reaction Vessels on November 7, 2025, due to manufacturing deformities. These defects can cause instrument errors that delay patient results. Healthcare providers and patients should stop using the affected vessels immediately.

Quick Facts at a Glance

Recall Date
November 7, 2025
Hazard Level
HIGH
Brand
Beckman Coulter
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter, Inc. or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall involves Access 2 Reaction Vessels, Catalog Number 81901. The affected lots include P243943, P243971, P244202, P244344, P244345, P250001, P250002, P250003, P250004, and P250005. The vessels were distributed nationwide in the U.S.

The Hazard

Certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. A small protrusion or hair-like deformity on the bottom of the vessel can cause instrument errors, including pipetting and wash carousel errors.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. The potential for delays in patient results poses a significant risk to patient care.

What to Do

Stop using the Access 2 Reaction Vessels immediately. Follow the recall instructions provided by Beckman Coulter and contact your healthcare provider for further guidance.

Contact Information

For more information, contact Beckman Coulter, Inc. or visit their website. The recall notification was sent via letter.

Key Facts

  • Recall date: November 7, 2025
  • Quantity recalled: 38,225 units
  • Affected catalog number: 81901
  • Potential for instrument errors
  • No reported injuries or deaths

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeImmunoassay Reaction Vessels
Sold At
Unknown

Product Details

Model Numbers
UDI-DI: 15099590180249
Lot Numbers: P243943
P243971
P244202 P244344
P244345
+4 more
Affected States
ALL
Report Date
December 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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