Date Initiated by Firm | October 20, 2015 |
Create Date | November 18, 2015 |
Recall Status1 |
Terminated 3 on November 09, 2016 |
Recall Number | Z-0317-2016 |
Recall Event ID |
72471 |
510(K)Number | K052115 K113046 K113501 |
Product Classification |
Enzyme immunoassay, benzodiazipine - Product Code JXM
|
Product | THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU,
MTPA-8MBAU
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. |
Code Information |
G150094 G150136 |
Recalling Firm/ Manufacturer |
Ameditech Inc 9940 Mesa Rim Rd San Diego CA 92121-2910
|
For Additional Information Contact | 858-535-1968 |
Manufacturer Reason for Recall | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. |
FDA Determined Cause 2 | 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 amt.fieldaction@alere.com. For questions regarding this recall call 858-535-1968. |
Quantity in Commerce | 220 units |
Distribution | Worldwide Distribution - US (nationwide) and Internationally to Australia. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JXM 510(K)s with Product Code = JXM
|