Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 Recalled by MedtestDx, Inc. Due to Vial to vial variation in the fill volume...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact MedtestDx, Inc. directly.
Affected Products
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.
Quantity: 79 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MedtestDx, Inc.
MedtestDx, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report