The Recall Desk
LowFDA (Devices)·Z-0354-2019·Announced 2018-11-07

Beckman Coulter Sorting-Drive 4.2 Software Recalled for Barcode Errors

Beckman Coulter is recalling 25 units of Sorting-Drive 4.2 software due to a defect that may generate incorrect barcode IDs when printing consecutively numbered 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 recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The defect involves incorrect barcode generation, which is a functional error rather than a direct physical or biological hazard.

Plain-English summary

Beckman Coulter Inc. is recalling 25 units of the Sorting-Drive 4.2 User Kit, Part No. B73488. This software package, manufactured by Beckman Coulter Biomedical GmbH, is an optional component used with the Automate 2500 Family of products to automate the sorting, decapping, and archiving of samples. The affected software versions are v4.2.1 and 4.2.

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

The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries. Users of the Sorting-Drive 4.2 software should contact Beckman Coulter for further instructions on how to address the barcode generation error.

The recalled product

Product
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and
Affected units
25

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 →