Z-0538-2016Class III
ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W
Ameditech, Inc. / initiated 2015-11-16 / Terminated / root cause: manufacturing process
Ameditech Inc began a recall of ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W 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-0538-2016
- Classification
- Class III
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ameditech, Inc.
- Product
- ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W
- 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
- 1,680 kits
- Distribution
- Nationwide Distribution.
- Product codes and lots
- 152171 152216 153103
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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