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Response Biomedical Recalls

1 recall on record · March 18, 2020 to March 18, 2020 · Medical Devices

March 18, 2020Medical DevicesFDA

Response Biomedical Corp. recalls Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C

Hazard: The 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 up to 57% signal loss within 11 months. Shelf-life of product is 24 months.

Response Biomedical Recalls | RecallWatchUSA