Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specificatio
Summary
The FDA issued a Class I for Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinit by Abbott Molecular, Inc.. Reason: There is a potential for false positive results..
Details
Source
Device Recall
External ID
Z-0005-2022
Action Date
2021-10-20
Status
Terminated
Category
device
Product Description
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Lot/Code Info: List Number: 09N79-096, UDI 00884999049390; Lot/Serial, Expiration: 514074, 09/15/2021; 519243, 05/10/2022; 519243, 5/10/2022; 522088, 8/4/2022; 522128, 8/26/2022; 523152, 10/10/2022; 524433, 1/15/2023; 526710, 1/21/2023; 527845, 2/8/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.oo
Quantity Affected: 8469 units
Reason for Recall
There is a potential for false positive results.
Distribution
Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-02
Company
Des Plaines, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 174 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-0005-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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