CLASS III Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
iCup DX 8 Panel w/Adulterant recalled by Ameditech
Ameditech is recalling iCup DX 8 Panel w/Adulterant, 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
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-0506-2016
- 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
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is iCup DX 8 Panel w/Adulterant recalled?
Yes. Ameditech recalled iCup DX 8 Panel w/Adulterant on 16 Nov 2015. The recall is Class III and its status is Terminated. Recall number Z-0506-2016.
Why was it recalled?
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.
Which lots are affected?
141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650
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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