Recall Z-2316-2017 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Medtest Holdings, Inc.
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
| Date | Oct 23, 2014 |
| Status | Terminated |
| Reason | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification. |
| 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 | 10260 volume vials |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942458 | PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED Randox Laboratories, Ltd., Mar 13, 1995 |