The Recall Desk
LowFDA (Devices)·Z-0359-2019·Announced 2018-11-07

Beckman Coulter Sorting-Drive Software Recall for Barcode Printing Errors

Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect IDs for tube labels.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the source text does not report any injuries or illnesses.

Plain-English summary

Beckman Coulter Inc. is recalling 58 units of the Sorting-Drive Professional Kit (Part No. A94144) and related software versions 4.2 and 4.2.1. The recall affects the Sorting-Drive 4.2.1 User Kit (PN B95347) and the Sorting-Drive 4.2.1 Software DVD (PN B95346). These products were distributed worldwide, including in the United States and numerous international locations.

The recall is due to a defect in the optional Barcode Counter function introduced in software version 4.2. When printing consecutively numbered tube labels, the system incorrectly converts numbers containing consecutive multiple zeroes in the middle, which can result in wrong barcode IDs. The manufacturer states that this issue does not affect automated label creation, the reprinting of individual labels, or any other system functions.

Users of the affected software should contact Beckman Coulter for instructions on how to resolve the issue. The recall is classified as Class III by the FDA, indicating that the defect is unlikely to cause adverse health consequences.

The recalled product

Product
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive 4.2
Affected units
58

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)

  • v4.2.1 (and 4.2
  • discontinued)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →