CLASS III Device recall · Reported 31 May 2017 · FDA Enforcement Report

Pointe Scientific Chemistry Controls Level I and II LEVl recalled

Medtest Holdings is recalling Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white, distributed nationwide in the US. The recall was initiated on 15 May 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).

Quantity recalled132919 Vol vials

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-2121-2017
FDA event ID: 77083
Recalling firm: Medtest Holdings, Canton, MI
Classification: Class III
Status: Terminated
Recall initiated: 15 May 2014
FDA classified: 20 May 2017
Reported: 31 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

15 May 2014	Recall initiated by company
20 May 2017	Classified by FDA	+1101 days
31 May 2017	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

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

Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

Which lots are affected?

Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).

Where was it sold?

Nationwide

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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