Beckman Coulter iPAW 4.2 Software Recalled for Barcode Labeling Errors
Beckman Coulter is recalling the iPAW 4.2 User Kit software because a specific manual barcode printing function may generate incorrect IDs for sample tubes.
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 is defined as unlikely to cause adverse health consequences. The hazard is a software defect leading to potential labeling errors, with no reported injuries or illnesses.
Plain-English summary
Beckman Coulter Inc. is recalling the iPAW 4.2 User Kit (Part No. B73489), a software package that includes the iPAW software application CD version 4.2. The recall involves 14 units distributed worldwide, including the United States and numerous international locations. The software is primarily used to copy existing barcode IDs to replace deteriorated labels on individual sample tubes.
The recall is due to a defect in the Sorting-Drive software version 4.2, released in October 2015. A new optional Barcode Counter function used for manual printing of consecutively numbered tube labels incorrectly converts numbers containing consecutive multiple zeroes in the middle. This error can potentially lead to wrong barcode IDs being printed. The firm reports that this issue does not affect automated label creation, the reprinting of individual labels, or any other system functions.
Users of the iPAW 4.2 User Kit should stop using the optional Barcode Counter function for manual printing of consecutively numbered tube labels. No other actions are specified in the source text for consumers or healthcare facilities.
The recalled product
- Product
- Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This function is primarily used to copy an existing barcode ID to replace the…
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 14
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- High
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighBeckman Coulter MicroScan LabPro Software Recall for Manual Editing Error
FDA (Devices) · 2015-09-30
- ModerateBeckman Coulter Recalls MicroScan LabPro Data Management System Software
FDA (Devices) · 2016-12-21
- ModerateBeckman Coulter Recalls DxA 5000 Automated Sample Handling Systems
FDA (Devices) · 2020-09-30
- ModerateBeckman Coulter Recalls MicroScan LabPro Software Due to Editing Error
FDA (Devices) · 2016-04-06
- ModerateBeckman Coulter LabPro Data Management System Software Update Recall
FDA (Devices) · 2020-04-15
- HighBeckman Coulter DxA Automation System software defect may cause incorrect test results
FDA (Devices) · 2023-07-26