Pointe Scientific, Inc.

FDA recalling firm · 3 enforcement events · 3 product records · 2014–2015 · MI

Pointe Scientific, Inc. has 3 FDA enforcement events on this register (3 product records) between 2014 and 2015: 3 device; the busiest year was 2015 with 2.

0% of its events are Class I; the most common class is Class III (2). 0 events are listed as ongoing; the recalling firm's address is in MI.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
19 May 2015	Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative…	Device	Class II	1	Terminated
13 Mar 2015	Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE…	Device	Class III	1	Terminated
12 Dec 2014	Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.	Device	Class III	1	Terminated

By type and class

Device3

Class III2

Class II1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Pointe Scientific, Inc. by year initiated.

Questions and answers

How many FDA recalls has Pointe Scientific, Inc. had?

3 enforcement events (3 product records) on this register, 2014–2015: 3 device.

Are any Pointe Scientific, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Pointe Scientific, Inc. recalls?

2 Class III, 1 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.