MedtestDx, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2768-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 15, 2015

Date Posted: September 23, 2015

Recall Number: Z-2768-2015

Event ID: 71993

Reason for Recall:

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.

Status: Terminated

Product Quantity: 79 kits

Code Information:

Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated