Device recall: Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic…

Class III FDA enforcement event 76985. Recall start date: 15 Feb 2012. Status in the FDA record: Terminated. Termination date: 2 Jun 2017.

Reason for recall, in the words of FDA

A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Medtest Holdings, Inc. started this device recall on 15 Feb 2012. The firm address in the FDA record is in Canton, MI. FDA put the recall in Class III. FDA event 76985 has 1 product record. The first FDA enforcement report date is 24 May 2017. The record gives the status Terminated, with the termination date 2 Jun 2017.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide Distribution

Recalling firm

Medtest Holdings, Inc., Canton, MI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 76985: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2116-2017	Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.	119.168L across All lots	Class III	Terminated	24 May 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class III: 6%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of 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
23 Oct 2014	MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rub	Device	Class III	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
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

Medtest Holdings, Inc.: all 10 events

Official channels

FDA enforcement report Z-2116-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 76985. https://recallregister.com/fda/iii/76985/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide Distribution
What quantity of product is in FDA event 76985?: The FDA record gives this quantity: 119.168L across All lots
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 6% of the 823 device events that started in 2012 are in Class III.