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102 reported ongoing
105 records in this archive. Latest source date Jun 4, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Class IIReported ongoing
Distribution: International distribution to the countries of Belgium and the Netherlands.
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Class IIReported ongoing
Distribution: International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany,...
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Class IReported ongoing
Distribution: Worldwide
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Class IIReported ongoing
Distribution: US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class IIReported ongoing
Distribution: US Nationwide distribution.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 105 records, including 102 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.