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U.S. Department of Health and Human Services

Class 2 Device Recall ProScreen

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  Class 2 Device Recall ProScreen see related information
Date Initiated by Firm October 20, 2015
Create Date November 18, 2015
Recall Status1 Terminated 3 on November 09, 2016
Recall Number Z-0315-2016
Recall Event ID 72471
510(K)Number K052115  K113046  K113501  
Product Classification Enzyme immunoassay, benzodiazipine - Product Code JXM
Product ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX;
ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M,
PSCupA-10MO, PSCUp-10AB;
ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM;
ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX,
PSD-10M, PSD-10CMO3, PSD-10APO-300;
ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300;
ProScreen 11 Panel Dip Card, Item No. PSD-11MT;
ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU;
ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP;
ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
ProScreen 5 Panel Dip Card, Item No. PSD-5MB;
ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300;
ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU;
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU;
ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300,
PSD-6MB, PSD-6BUPO;
ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M;
ProScreen 8 Panel Dip Card, Item No. PSD-8P;
ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P;
ProScreen 9 Panel Dip Card, Item No. PSD-9P;
ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W;
ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W;
ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W;
ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W,
PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300;
ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W;

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.


































































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Code Information 134545 150270 150542 134346 134347 141739 141836 141841 142565 142951 143151 143875 144102 144106 144239 144241 144362 150192 150198 150629 150630 150651 150791 150959 151037 151358 151359 143402 143813 144240 151395 134181 141028 141458 142039 142111 142385 142396 142498 142717 142823 142957 142972 143514 143828 144298 144301 144308 144309 144310 144519 144520 144540 144541 150087 150108 150145 150169 150514 150516 150639 150810 151018 151523 151524 143574 143947 145055 150037 150187 150310 150457 150660 150881 150941 151465 151468 142864 150051 150512 141889 144364 150792 141747 142054 144104 144363 150689 151066 151067 142284 150208 150509 150643 150936 140904 141374 141527 141746 144261 144537 151282 151295 144336 150879 G150042 G140426 G150017 G150048 G150069 G150111 G150146 140905 140906 141014 141027 141225 141228 141347 141440 141446 141510 141740 141742 141751 144334 144335 144539 144545 144546 150148 150154 150168 150232 150462 150478 150601 150602 150653 150808 150938 151283 142514 143150 143404 143858 144394 144440 150482 150513 150904 151372 142528 143154 143405 150339 151297 150050 142529 142971 143155 143474 144547 150286 150654 150786 143803 150003 150207 150828 143874 144562 150182 150231 150325 141296 141372 141475 141476 141583 141842 143825 144227 
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 31,530 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 and Original Applicant = AMEDITECH, INC.
510(K)s with Product Code = JXM and Original Applicant = FIRST CHECK DIAGNOSTICS LLC
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