Date Initiated by Firm | November 16, 2015 |
Create Date | December 24, 2015 |
Recall Status1 |
Terminated 3 on November 09, 2016 |
Recall Number | Z-0493-2016 |
Recall Event ID |
72651 |
510(K)Number | K052115 K113046 K113501 |
Product Classification |
Enzyme immunoassay, benzodiazipine - Product Code JXM
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Product | DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D |
Code Information |
143978 144485 151982 153095 |
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 | 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. |
FDA Determined Cause 2 | 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 amt.fieldaction@alere.com. |
Quantity in Commerce | 340 kits |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JXM 510(K)s with Product Code = JXM
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