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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About This Product

Access 2 Reaction Vessels are disposable plastic tubes used in medical labs to process patient samples and perform quality control tests. They are crucial for accurate testing in immunoassay systems.

Why This Is Dangerous

Manufacturing deformities in the Reaction Vessels can lead to errors in laboratory instruments, affecting the accuracy and timeliness of patient results.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may cause delays in patient testing and results, which could impact patient care and treatment decisions.

Practical Guidance

How to identify if yours is affected

  1. Check the catalog number (81901) on the product.
  2. Verify the lot numbers against the recalled list: P243943, P243971, P244202, P244344, P244345, P250001, P250002, P250003, P250004, P250005.
  3. If your product matches, it is affected by the recall.

Where to find product info

The catalog number and lot numbers are usually printed on the packaging or label of the Reaction Vessels.

What timeline to expect

Expect a processing time of 4-6 weeks for any refunds or replacements once you follow the recall instructions.

If the manufacturer is unresponsive

  • Contact Beckman Coulter again to follow up on your request.
  • Document all correspondence for your records.
  • Consider filing a complaint with the FDA if you do not receive a response.

How to prevent similar issues

  • Always check for product recalls before purchasing medical devices.
  • Look for FDA approval and compliance certifications on medical products.
  • Ensure that medical devices are sourced from reputable suppliers.

Documentation advice

Keep records of your purchase, including receipts and any correspondence regarding the recall.

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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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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
Recall Status
ACTIVE

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