Automated diagnostic analyzer from Abbott recalled for waste pressure buildup
Abbott is recalling 260 Alinity s System analyzers due to a design defect allowing waste pressure to build up and spray operators. No injuries reported.
What this means for you
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: FDA Class II without reported illnesses or injuries. The design defect poses a potential spray hazard to operators, but no injuries have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Abbott Laboratories, Inc. is recalling the Alinity s System (Model LN 06P16-01, Serial Numbers AS1001 through AS1330), an automated immunoassay analyzer used in blood donor screening, plasma screening, and organ donor centers, hospitals, and reference laboratories. A total of 260 systems have been distributed worldwide.
A design defect in both the hardware and software can allow liquid waste pressure to build up within the system. This pressure buildup has the potential to cause waste material to spray toward users and operators during normal operation.
The recalled systems are distributed worldwide, including in the United States, Australia, and numerous other countries in Europe, the Middle East, Asia, and Africa. Affected facilities include blood donor centers, organ donor centers, hospitals, and reference laboratories.
The recalled product
- Product
- Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- pressure-buildup
- spray-hazard
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)
- Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330
Distribution
Distributed nationwide across the United States.
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