Z-2316-2017Class III

MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass...

Name: Z-2316-2017 MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass...
Creator: Medtest Holdings, Inc.
Published: 2014-10-23
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2014-10-23 / Terminated

FDA source

Medtest Holdings, Inc. began a 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 black plastic screw... on 2014-10-23. FDA classified it as Class III and gives the reason as "MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2316-2017
Classification: Class III
Status: Terminated
Initiated: 2014-10-23
Posted: 2017-06-08
Terminated: 2017-11-17
Recalling firm: Horiba Instruments Incorporated
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).
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
FDA root cause: Under Investigation by firm
Action: An technical bulletin/advisory was issued to alert users of the MedTest DX Chemistry Controls catalog numbers HNC200 and HEC200 that revisions have been made for the assigned ranges when used with Arkray Spotchem - EZ Dry Chemistry Analyzer. Customer label corrections were sent to customers who purchased the affected control lots on the following dates: " 10/23/14 technical bulletin HEC200101014 via US mail. " 12/3/14 technical bulletin HNCHEC200120114 via US mail. " 4/6/15 technical bulletin HNCHEC200031015 via US mail. " 5/29/15 technical bulletin HNC200052115 via US mail and email.
Quantity in commerce: 10260 volume vials
Distribution: US Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2316-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2316-2017	Class III	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-08

Product code JJY

K942458Class IPrecision-Multi-Sera - Human - Normal and ElevatedRandox Laboratories, Ltd. / cleared 1995-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)