CLASS III Device recall · Reported 30 Dec 2015 · FDA Enforcement Report

11 Panel Card (OPI 300) w/Adult recalled by Ameditech

Ameditech is recalling 11 Panel Card (OPI 300) w/Adult, distributed nationwide in the US. The recall was initiated on 16 Nov 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codes144376

Quantity recalled50 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-0487-2016
FDA event ID: 72651
Recalling firm: Ameditech, San Diego, CA
Classification: Class III
Status: Terminated
Recall initiated: 16 Nov 2015
FDA classified: 24 Dec 2015
Reported: 30 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Nov 2015	Recall initiated by company
24 Dec 2015	Classified by FDA	+38 days
30 Dec 2015	Published 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

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

Product as listed by the FDA

11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is 11 Panel Card (OPI 300) w/Adult recalled?

Yes. Ameditech recalled 11 Panel Card (OPI 300) w/Adult on 16 Nov 2015. The recall is Class III and its status is Terminated. Recall number Z-0487-2016.

Why was it recalled?

Which lots are affected?

144376

Where was it sold?

Nationwide Distribution.

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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