The Recall Desk
ModerateFDA (Devices)·Z-0153-2014·Announced 2013-11-13

Beckman Coulter ISE REF Valve Recall for Chemistry Analyzers

Beckman Coulter is recalling ISE REF Valves for AU480, AU680, and AU5800 analyzers due to premature valve failure that may affect test accuracy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential inaccuracy of test results due to mechanical valve failure, with no reported injuries, illnesses, or deaths in the source text.

Plain-English summary

Beckman Coulter Inc. is recalling ISE REF Valves (Part No. MU7638) used in AU480, AU680, and AU5800 Automated Chemistry Analyzers. The recall was initiated because the company confirmed that some units can experience premature failure of the ISE REF (Reference) valve.

Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, the accuracy of the ISE test results may be affected.

A total of 4,584 units were distributed worldwide, including 1,173 units in the United States. Distribution included the US (nationwide), Canada, Vietnam, Zambia, and Zimbabwe. Users should check their ISE units for air bubbles in the REF solution tubing and contact Beckman Coulter for further instructions.

The recalled product

Product
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • AU480
  • Item Code: B11803 N3152300 N3152400 N3152500 N3152600 N3912600 AU680
  • Item Code: A94927 A94928 A94929 A94930 N9028030

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

See all →

Same hazard · inaccurate results

See all →