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MedtestDx Recalls

1 recall on record · September 23, 2015 to September 23, 2015 · Medical Devices

September 23, 2015Medical DevicesFDA

MedtestDx, Inc. recalls MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white se

Hazard: Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.

MedtestDx Recalls | RecallWatchUSA