Abbott Recalls Alinity i Processing Modules Due to Gear Pump Assembly Issue
Abbott is recalling Alinity i Processing Modules because a gear pump assembly issue causes foaming and dried residue in the wash buffer reservoir.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a mechanical defect causing fluid residue, which fits the criteria for a moderate severity voluntary precautionary recall without reported harm.
Plain-English summary
Abbott GmbH & Co. KG is recalling 434 units of the Alinity i Processing Module, a fully automated immunoassay analyzer. The recall involves specific part numbers: 03R65-01, A-30108552-01, and A-30109694-01. The affected serial numbers range from Ai01001 to Ai01455, plus Ai01457 and Ai01459 for the first part number, while all serial numbers are affected for the other two part numbers.
The recall is due to an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01). This defect results in foaming or bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried buffer residue. The foaming is caused by an improper calibration of the pump's operating speed.
The products were distributed worldwide. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and auto
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 434
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 (3)
- (a) Serial Numbers: Ai01001 - Ai01455
- Ai01457
- Ai01459 (b) all Serial Numbers (c) all Serial Numbers
Distribution
Distribution scope not specified by the agency.
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