Beckman Coulter iPAW Software Recall for Barcode Label Errors
Beckman Coulter is recalling iPAW 4.2.1 software due to a defect that may generate incorrect barcode IDs when printing consecutive 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. The hazard involves potential mislabeling of barcodes, which is a moderate risk but does not involve immediate physical injury or high-risk pathogens.
Plain-English summary
Beckman Coulter Inc. is recalling the iPAW 4.2.1 User Kit for Windows XP and Windows 10 (Part No. B95343). This software package, manufactured by Beckman Coulter Biomedical GmbH, is used for manual printing of barcodes. The recall involves 29 units distributed worldwide, including the United States and numerous international locations.
The recall is due to a defect in the Sorting-Drive software version 4.2, released in October 2015. When using the optional Barcode Counter function to print consecutively numbered tube labels, the system incorrectly converts numbers containing consecutive multiple zeroes in the middle. This error can result in wrong barcode IDs being printed on the labels.
The firm reports that this defect does not affect automated label creation or the reprinting of individual labels, and no other system functions are impacted. Users of this specific software version should contact Beckman Coulter for further instructions on how to proceed.
The recalled product
- Product
- Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for…
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 29
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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