Z-0310-2016Class II
EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the...
Ameditech, Inc. / initiated 2015-10-20 / Terminated / root cause: manufacturing process
Ameditech Inc began a recall of EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug... 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-0310-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ameditech, Inc.
- Product
- EDI BZO UNCUT SHEET-CARD, Item No. 100170 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
- 70364 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia.
- Product codes and lots
- 134268 134898 140206 140218 140453 140551 141053 141129 143471 143553 144468 144557 150317 150531 150606 150638 150834 151154 152021 152104 134067 134504 140495 141010 141128 141197 143716 143784 143866 144003 144042 144199 144270 144332 144443 144502 144555 150237 150347 150440 150901 150989 151239 151925 151984 152003 152103
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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