Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening,
Summary
The FDA issued a Class II for Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro by Abbott Laboratories, Inc. Reason: A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators..
Details
Source
Device Recall
External ID
Z-2276-2021
Action Date
2021-08-18
Status
Ongoing
Category
device
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.
Lot/Code Info: Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330
Quantity Affected: 260 systems
Reason for Recall
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-12
Company
Irving, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Laboratories, Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories, Inc have FDA actions?
Abbott Laboratories, Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2276-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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