FDA Device recall Z-2316-2017
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and bla…
- FDA Device
- Class III
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class III recall of MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and bla… by Medtest Holdings, citing medTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2316-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-10-23 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtest Holdings |
| Distribution | US |
Product
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).
Reason
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
Identifiers
| code_info | HEC200: " 616UE, Mfr. Date 2013-02, Exp. 2017-01 " 652UE, Mfr. Date 2013-07, Exp. 2017-07 " 720UE, Mfr. Date 2014-08…HEC200: " 616UE, Mfr. Date 2013-02, Exp. 2017-01 " 652UE, Mfr. Date 2013-07, Exp. 2017-07 " 720UE, Mfr. Date 2014-08, Exp. 2018-07 HNC200: " 858UN, Mfr. Date 2013-07, Exp. 2018-07 " 941 UN, Mfr. Date 2014-07, Exp. 2018-06 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2316-2017%22
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