Reported Jun 14, 2017 · Terminated
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with…
Medtest Holdings, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtest Holdings, Inc. · 5449 Research Dr · Canton, MI · 48188-2261
Is this the product you have?
- 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 UsageMedTest 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)
- Lot codes and dates
- HEC200
" 616UEMfr. Date 2013-02Exp. 2017-01 " 652UEMfr. Date 2013-07Exp. 2017-07 " 720UEMfr. Date 2014-08Exp. 2018-07
- HNC200
" 858UNMfr. Date 2013-07Exp. 2018-07 " 941 UNMfr. Date 2014-07Exp. 2018-06
- HEC200
- Amount recalled
- 10260 volume vials
Where it was sold
- Nationwide
Why it was recalled
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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