Beckman Coulter Sorting-Drive Software Recalled for Barcode Label Errors
Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect tube label IDs.
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 by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor functional issues.
Plain-English summary
Beckman Coulter Inc. is recalling 495 units of the Sorting-Drive Product Part and Sorting-Drive Plus Kit, specifically software versions 4.2 and 4.2.1. The software facilitates Laboratory Information System (LIS) connections to AutoMate 2500 Family systems. The affected units were 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. The manufacturer states that automated label creation, reprinting of individual labels, and other system functions are not affected by this issue.
Users of the affected software versions should contact Beckman Coulter for instructions on how to resolve the issue. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 495
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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