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Biogenex Laboratories Recalls

1 recall on record · July 30, 2014 to July 30, 2014 · Medical Devices

July 30, 2014Medical DevicesFDA

Biogenex Laboratories, Inc. recalls InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

Hazard: Product was distributed without 510(k) approval.

Biogenex Laboratories Recalls | RecallWatchUSA