Beckman Coulter Recalls iPAW Software Due to Barcode Labeling Errors
Beckman Coulter is recalling iPAW software versions 4.2 and 4.2.1 because a specific barcode printing feature may generate incorrect IDs for tube labels.
What this means for you
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 indicates a low risk of adverse health consequences. The defect is a software labeling error that does not involve a direct physical hazard or reported injuries.
Plain-English summary
Beckman Coulter, Inc. is recalling the Intelligent Peri-Analytical Workstation (iPAW) software, specifically versions 4.2 and 4.2.1. The recall involves 283 units distributed worldwide, including the United States and numerous international markets. The iPAW system functions as a software client for specimen tracking and workload statistics, or as a physical workstation for manual sorting and label printing.
The recall is due to a defect in the optional Barcode Counter function introduced in software version 4.2. When users print consecutively numbered tube labels using this specific feature, 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 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 defect is limited to the manual printing of consecutively numbered labels using the Barcode Counter option.
The recalled product
- Product
- Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for manua
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 283
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 →- 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
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- High
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02