Abbott Accelerator APS Aliquoter Module Recalled for Sample Dilution Risk
Abbott is recalling 11 Accelerator APS Aliquoter Modules because a clot detection error may cause distilled water to dilute samples, leading to incorrect clinical results.
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 II. The hazard involves incorrect test results due to sample dilution, which is a significant quality issue but does not involve direct physical injury, death, or high-risk pathogens, fitting the Moderate category for a device recall without reported harm.
Plain-English summary
Abbott Laboratories is recalling 11 units of the Accelerator APS Aliquoter Module (List number: 07L40). The module is part of the ACCELERATOR APS Workcell, a modular system designed to automate sample handling and processing in clinical laboratories. The recall covers all serial numbers currently in the field.
The recall is issued because an Aliquoter Module (AQM) clot detection error may cause a portion of distilled water from the hydraulic circuit to be dispensed into the Primary Tube. This results in sample dilution, which could lead to incorrect clinical test results.
The affected units were distributed worldwide, including nationwide in the United States (specifically North Carolina, North Dakota, South Carolina, and Tennessee) and in the United Kingdom, France, New Zealand, Pakistan, and Turkey. Clinical laboratories should contact Abbott Laboratories for instructions on how to proceed with the recall.
The recalled product
- Product
- Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay a
- Manufacturer
- Abbott Laboratories
- Affected units
- 11
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 (1)
- All serial numbers in the field
Distribution
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