BD FACSDuet Sample Preparation System software defect causes inaccurate specimen volumes
The BD FACSDuet sample preparation system may dispense specimen volumes that are 3% to 20% higher in one tube versus another, leading to inaccurate blood counts, delayed test results, and potential additional blood collection. The defect affects 130 systems distributed across the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of laboratory equipment with a confirmed defect causing measurable specimen volume and count errors (3-20% differences) that could delay patient diagnosis and treatment. No illnesses or injuries have been reported. Per the rubric, when no illnesses/injuries are reported but the risk of harm is real and significant, the score is at most 3 (High).
Plain-English summary
The BD FACSDuet Premium Sample Preparation System and BD FACSDuet Sample Preparation System (Base), when used with software version 1.4.1, are subject to recall due to a specimen volume dispensing defect.
The system's multidispense feature may dispense specimen volume into the first tube at least 3% higher than the volume in the second tube. When used with Trucount Tubes, this increased volume in the first tube may result in absolute blood counts that are up to 20% higher in the first tube compared to the second tube. These inaccurate measurements could result in delayed patient test results and treatment decisions, and may necessitate additional blood collection from patients.
130 affected units have been distributed to facilities in 13 US states (New Jersey, Utah, Wisconsin, Texas, Idaho, Alaska, Minnesota, Massachusetts, Maryland, Tennessee, Michigan, California, and Virginia) and 22 countries worldwide, including Canada, the United Kingdom, Japan, Australia, Germany, and others. The recall applies to specific product reference numbers and serial numbers identified by the manufacturer.
Healthcare providers using affected units should contact Becton, Dickinson and Company for remediation guidance. Facilities should verify whether their equipment serial numbers match those listed in the official FDA recall notice.
The recalled product
- Product
- BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Affected units
- 130
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 (20)
- REF/UDI-DI/Serial Numbers: 666340/382906663405/9230010101
- 9230010102
- 9230010103
- 9230010104
- 9230010105
- 9230010107
- 9230010108
- 9230010109
- 9230010112
- 9230010113
- 9230010114
- 9230010115
- 9230010116
- 9230010118
- 9230010119
- 9230010120. 666339/9230000102
- 9230000103
- 9230000104
- 9230000105
- 9230000106
Distribution
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