Beckman Coulter Recalls Sorting-Drive Software Due to Barcode Errors
Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because the manual barcode printing function may generate incorrect IDs for sample tubes.
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 agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The defect is a software error affecting manual label printing, with no reported injuries or illnesses.
Plain-English summary
Beckman Coulter Inc. is recalling the Sorting-Drive 4.2.1 User Kit software package (Part No. B95347) and the discontinued version 4.2. This software is an optional component used with the Automate 2500 Family of products. The recall involves 54 units distributed worldwide, including the United States and numerous international locations.
The recall is due to a defect in the optional Barcode Counter function used for manual printing of consecutively numbered tube labels. The system incorrectly converts numbers containing consecutive multiple zeroes in the middle, which can result in wrong barcode IDs being printed. The firm states that automated label creation, reprinting of individual labels, and other system functions are not affected by this issue.
Users of the Sorting-Drive software should stop using the manual barcode printing function for consecutively numbered labels and contact Beckman Coulter for instructions on how to proceed. The software is primarily used to copy existing barcode IDs to replace deteriorated labels on individual sample tubes.
The recalled product
- Product
- Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, 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 Sorting-Drive 4.2.1 Use
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 54
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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