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2 reported ongoing
7 records in this archive. Latest source date May 24, 2023.
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.
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, FL, OH, & SC.
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, FL, OH, & SC.
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
Class IIReported terminated
Distribution: TX
Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't no...
Class IIReported terminated
Distribution: TX
Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.
Class IIIReported terminated
Distribution: US Nationwide distribution in the states of CT, TX.
May show unexpected locus specific signals in addition to those at 14q32.
Class IIIReported terminated
Distribution: MN
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green....
Class IIReported terminated
Distribution: US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 7 records, including 2 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.