Z-0316-2016Class II
The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse...
Ameditech, Inc. / initiated 2015-10-20 / Terminated / root cause: manufacturing process
Ameditech Inc began a recall of The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the... on . FDA classified it as Class II and gives the reason as "Ameditech is recalling drug abuse tests because they have shown reduced reactivity". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0316-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ameditech, Inc.
- Product
- The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
- Product code
- JXM Enzyme Immunoassay, Benzodiazepine
- Reason for recall
- Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Ameditech Inc. sent an Urgent Medical Device Recall Letter to al affected customers on October 20, 2015, to inform them that Ameditech is recalling affected lots of Ameditech's Drugs of Abuse Tests because they have shown reduced reactivity for up to three of the nineteen Benzodiazepine (BZO) compounds. The letter informs customers of the actions to be taken. Customers were instructed to complete and return the customer verification form to (858) 677-0243 or scan and email to [email protected]. For questions regarding this recall call 858-535-1968.
- Quantity in commerce
- 2,240 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia.
- Product codes and lots
- G140422-C G150059-C G150063-C G150132-C
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0298-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0299-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0300-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0301-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0302-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0303-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0304-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0305-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0306-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0307-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0308-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0309-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0310-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0311-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0312-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0313-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0314-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0315-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0316-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0317-2016 | Class II | Terminated | Voluntary: Firm initiated |
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