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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- 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.
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