FDA Device recall Z-2768-2015
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml by Medtestdx, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2768-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-15 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtestdx |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2768-2015%22
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