Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Summary
The FDA issued a Class III for Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITEC by Abbott Laboratories. Reason: Reaction vessels may contain a potential contaminant that could affect their optical performance..
Details
Source
Device Recall
External ID
Z-0958-2023
Action Date
2023-01-25
Status
Ongoing
Category
device
Product Description
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Lot/Code Info: UDI-DI/Lots: 00380740129026/000586790 and 000586879
Quantity Affected: 70 cases
Reason for Recall
Reaction vessels may contain a potential contaminant that could affect their optical performance.
Distribution
US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-24
Company
Irving, TX
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 149 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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) 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 have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0958-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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