Exact Sciences Corporation
1 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (1)
Registered facilities (3)
- Exact Sciences Corporation- Discovery Campus FEI 3015728010 · WI
- Exact Sciences Corporation- Innovation Campus FEI 3008256118 · WI
- Exact Sciences Corporation- Legacy Campus FEI 3013841562 · WI
Recalls & enforcement
- Class IITerminated2017-04-28Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Exact Sciences Corporation — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10047364-exact-sciences-corporation/
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