🔍 RecallPedia

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. ¿¿¿

Class I - Dangerous
🏥 Medical Devices Recalled: October 20, 2015 Ameditech Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ameditech Inc
Reason for Recall:
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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. ¿¿¿

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0315-2016

Related Recalls

Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished Devices", NBCA-14A-PP/"Noble 1 Step + Cup" (THC50/COC150)+(OPI300/MET500)+ (AMP500/BZO300)+(BAR300/MTD300)+ (BOPG10/TCA1000)+(MDMA500/OXY100)+ (PCP25/PPX300) w/ Cr, Ni, pH, Bl, S.G."

Ameditech

Class I - Dangerous

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Aug 18, 2020 Other Medical Devices Nationwide View Details →

ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO ADULTERATION", IMCA-8CM5 /"ImmuTest Drugs of Abuse Cup (OXY100/MDMA500)+(PCP25/AMP1000)+COC150+MET500+OPI2000+THC50 with Cr, Ni, pH, Bl, S.G."

Ameditech

Class I - Dangerous

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Aug 18, 2020 Diagnostic Equipment Nationwide View Details →