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.
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 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…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- 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.
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