CLASS III Device recall · Reported 14 Jun 2017 · FDA Enforcement Report
MedTest DX Assayed Human Multi Sera Control Level recalled
Medtest Holdings is recalling MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200, distributed nationwide in the US. The recall was initiated on 23 Oct 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2316-2017
- FDA event ID
- 77062
- Recalling firm
- Medtest Holdings, Canton, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Oct 2014
- FDA classified
- 8 Jun 2017
- Reported
- 14 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Oct 2014 | Recall initiated by company | |
| 8 Jun 2017 | Classified by FDA | +959 days |
| 14 Jun 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 recalled?
Yes. Medtest Holdings recalled MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 on 23 Oct 2014. The recall is Class III and its status is Terminated. Recall number Z-2316-2017.
Why was it recalled?
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
Which lots are affected?
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
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtest Holdings
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator recalled | Medtest Holdings | Other | Nationwide |
| Device | CLASS III | Pointe Scientific Liquid Creatine Kinase Reagent Set Device recalled | Medtest Holdings | Device Malfunction | Nationwide |
| Device | CLASS III | The Pointe Scientific Ck-mb Isoenzyme Control Pointe recalled | Medtest Holdings | Other | AR, FL |
| Device | CLASS III | Pointe Scientific CRP(HS) Wide Range Control Set recalled | Medtest Holdings | Labeling Errors | 9 states |
| Device | CLASS II | Pointe Scientific Hitachi Total Bilirubin Rl Reagent recalled | Medtest Holdings | Other | 11 states |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |