Z-0308-2016Class II
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9...
Ameditech, Inc. / initiated 2015-10-20 / Terminated / root cause: manufacturing process
Ameditech Inc began a recall of DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10... 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-0308-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ameditech, Inc.
- Product
- DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C 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
- 1220 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia.
- Product codes and lots
- 140770 142294 151050 151527 142527 140998 142526 150596 151122 151196
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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