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.
Reported: August 18, 2021 Initiated: July 12, 2021 #Z-2276-2021
Product Description
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.
Reason for Recall
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Details
- Recalling Firm
- Abbott Laboratories, Inc
- Units Affected
- 260 systems
- Distribution
- Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Laboratories, Inc. Units affected: 260 systems.
Why was this product recalled? ▼
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2276-2021.
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