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MedtestDx, Inc. recalls MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white se
Recalled September 23, 2015 · FDA recall Z-2768-2015 · MedtestDx
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. · FDA Class II
Units
79 kits
Sold at
US Nationwide Distribution.
Description
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.
Product
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
Manufacturer(s)
MedtestDx, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →