Summary
The FDA issued a Class II for Alinity m System, Part No. 08N53-002 by Abbott Molecular, Inc.. Reason: There is a potential for abnormal (non-sigmoidal) amplification curves..
Details
Source
Device Recall
External ID
Z-0460-2022
Action Date
2022-01-12
Status
Ongoing
Category
device
Product Description
Alinity m System, Part No. 08N53-002
Lot/Code Info: Model 08N53-002, all serial numbers
Quantity Affected: 742 devices
Reason for Recall
There is a potential for abnormal (non-sigmoidal) amplification curves.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-06
Company
Des Plaines, IL
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 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Molecular, Inc. has 39 FDA actions in our database, including 30 recalls and 9 clearances.
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 Molecular, 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 Molecular, Inc. have FDA actions?
Abbott Molecular, Inc. has 39 FDA actions in our database, including 30 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0460-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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