The Recall Desk
ModerateFDA (Devices)·Z-0777-2023·Announced 2023-01-11

Beckman Coulter IRISpec glucose control false positive results with urine chemistry strips

Beckman Coulter is recalling IRISpec glucose control due to intermittent false positive results when used with specific urine chemistry strips. The recall may affect laboratory 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: FDA Class II recall with no reported illnesses or injuries. The hazard is intermittent false positive results in a diagnostic control, which affects laboratory test accuracy rather than causing direct patient harm.

Plain-English summary

Beckman Coulter is recalling the IRISpec CA/CB/CC glucose control because it produces intermittent false positive results when used with iChemVelocity Urine Chemistry Strips. The company discovered an increase in customer complaints about this issue.

Approximately 3657 units were distributed to the United States, Canada, Brazil, Korea, Mexico, Puerto Rico, and Taiwan. The product is a diagnostic control material used in clinical laboratory testing.

No illnesses or injuries have been reported. Customers with this product should contact Beckman Coulter for instructions.

The recalled product

Product
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Diagnostic Control
Hazard
  • false-positive

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 (2)

  • UDI/DI 10837461002611
  • Lot 565-21: 11-30-2022

Distribution

Distribution scope not specified by the agency.

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