Response Biomedical Corp.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Multi-Analyte Controls, All Kinds (Assayed)Product code JJY (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660
Recalls & enforcement
- Class IITerminated2019-03-15The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of …
FDA inspections (1)
- VAI2018-09-13Voluntary Action Indicated · Compliance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Response Biomedical Corp. (FEI 3004205692) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004205692-response-biomedical-corp/
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