Z-0516-2016Class III
ProScreen 10 Panel Cup, Item No. PSCup-10M
Ameditech, Inc. / initiated 2015-11-16 / Terminated / root cause: manufacturing process
Ameditech Inc began a recall of ProScreen 10 Panel Cup, Item No. PSCup-10M 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-0516-2016
- Classification
- Class III
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ameditech, Inc.
- Product
- ProScreen 10 Panel Cup, Item No. PSCup-10M
- 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
- 3,411 kits
- Distribution
- Nationwide Distribution.
- Product codes and lots
- 142596 142984 142985 143144 143145 143146 143240 143241 143351 143875 144102 144106 144239 144241 150651 151706 152165 152167 152168 153102 153107 153251 153411 153412 153633
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 |
FIRST ARTICLE / WEEKLY
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