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Arkray Factory USA Recalls
3 recalls on record · January 27, 2016 to June 26, 2019 · Medical Devices
Recalls by year
16
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 26, 2019Medical DevicesFDA
Arkray Factory USA, Inc. recalls AUTION HYBRID AU-4050
Hazard: This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
January 27, 2016Medical DevicesFDA
Arkray Factory USA, Inc. recalls arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Ure
Hazard: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
January 27, 2016Medical DevicesFDA
Arkray Factory USA, Inc. recalls arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quanti
Hazard: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.