CLASS III Device recall · Reported 5 Jul 2017 · FDA Enforcement Report

The Pointe Scientific Ck-mb Isoenzyme Control Pointe recalled

Medtest Holdings is recalling The Pointe Scientific Ck-mb Isoenzyme Control Pointe Scientific Ck-mb Level II Control, distributed in Arkansas, Florida. The recall was initiated on 22 Nov 2010 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03
Quantity recalled5 kits

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-2649-2017
FDA event ID
77453
Recalling firm
Medtest Holdings, Canton, MI
Classification
Class III
Status
Terminated
Recall initiated
22 Nov 2010
FDA classified
29 Jun 2017
Reported
5 Jul 2017
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

22 Nov 2010Recall initiated by company
29 Jun 2017Classified by FDA+2411 days
5 Jul 2017Published 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

Incorrect control range in product labeling

Product as listed by the FDA

The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

Where it was distributed

FL, AR, NICARAGUA, KOREA

ArkansasFlorida

Questions about this recall

Is The Pointe Scientific Ck-mb Isoenzyme Control Pointe Scientific Ck-mb Level II Control recalled?

Yes. Medtest Holdings recalled The Pointe Scientific Ck-mb Isoenzyme Control Pointe Scientific Ck-mb Level II Control on 22 Nov 2010. The recall is Class III and its status is Terminated. Recall number Z-2649-2017.

Why was it recalled?

Incorrect control range in product labeling

Which lots are affected?

Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03

Where was it sold?

FL, AR, NICARAGUA, KOREA

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.

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