The Recall Desk
ModerateFDA (Devices)·Z-1535-2020·Announced 2020-04-01

Beckman Coulter Recalls iChemVELOCITY Strips Due to Pad Switching Error

Beckman Coulter is recalling iChemVELOCITY Strips because the Leukocyte and Compensation pads were switched on some vials of lot 7212269M.

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 source text describes a manufacturing defect (pad switching) but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Beckman Coulter, Inc. is recalling iChemVELOCITY Strips, Catalog 800-7212, because the Leukocyte and Compensation pads were switched on some vials of lot number 7212269M. The recall involves 10,822 vials.

The affected product was distributed in the US, including Puerto Rico, Canada, and Taiwan. The specific UDI for the recalled items is 10837461002628.

Users should check their inventory for iChemVELOCITY Strips with lot number 7212269M and stop using them. They should contact Beckman Coulter, Inc. for further instructions on how to return or dispose of the affected product.

The recalled product

Product
iChemVELOCITY Strips, Catalog 800-7212
Affected units
10,822

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)

  • Catalog 800-7212
  • UDI 10837461002628
  • Lot 7212269M

Distribution

Distributed in 1 state: