Food, drugs, devices › Medtest Holdings, Inc.

Device recall: MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rub

FDA enforcement event 77062 · Class III · initiated 23 Oct 2014 · status Terminated · terminated 17 Nov 2017

DeviceVoluntary: Firm initiated1 product recordCanton, MI

FDA enforcement event 77062 is a device recall by Medtest Holdings, Inc. of Canton, MI, initiated 23 Oct 2014 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 17 Nov 2017. Initiation: voluntary: firm initiated. Medtest Holdings, Inc. has 10 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Medtest Holdings, Inc., Canton, MI.

Reason for recall

"MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification."

Distribution

"US Nationwide Distribution"

Product records

Recall number	Product	Quantity	Class	Status	Report date
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 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…	10260 volume vials	Class III	Terminated	14 Jun 2017

Context

4%of 2014 device events are Class III1,176 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Medtest Holdings, Inc.

Initiated	Product (first record)	Type	Class	Records
10 Aug 2018	Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of P	Device	Class III	1
3 Apr 2015	Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum	Device	Class II	1
15 May 2014	Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass via	Device	Class III	1
13 Mar 2012	Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin R	Device	Class II	1
15 Feb 2012	Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap.	Device	Class III	1
19 Oct 2011	Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK e	Device	Class III	1
8 Jul 2011	Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinet	Device	Class II	1
22 Nov 2010	The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit	Device	Class III	1
21 Jul 2009	Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2	Device	Class III	1

All 10 events for Medtest Holdings, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide Distribution"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 Nov 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.