Z-0506-2016Class III
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
Ameditech, Inc. / initiated 2015-11-16 / Terminated / root cause: manufacturing process
Ameditech Inc began a recall of iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016 on . FDA classified it as Class III and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0506-2016
- Classification
- Class III
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ameditech, Inc.
- Product
- iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
- Product code
- JXM Enzyme Immunoassay, Benzodiazepine
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at [email protected].
- Quantity in commerce
- 8,290 units
- Distribution
- Nationwide Distribution.
- Product codes and lots
- 141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0484-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0485-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0486-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0487-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0488-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0489-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0490-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0491-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0492-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0493-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0494-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0495-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0496-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0497-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0498-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0499-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0500-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0501-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0502-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0503-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0504-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0505-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0506-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0507-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0508-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0509-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0510-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0511-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0512-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0513-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0514-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0515-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0516-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0517-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0518-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0519-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0520-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0521-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0522-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0523-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0524-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0525-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0526-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0527-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0528-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0529-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0530-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0531-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0532-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0533-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0534-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0535-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0536-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0537-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0538-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0539-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0540-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0541-2016 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-0542-2016 | Class III | Terminated | Voluntary: Firm initiated |
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