| | Class 2 Device Recall DrugCheck |  |
| Date Initiated by Firm | November 01, 2010 |
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| Date Posted | August 31, 2011 |
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| Recall Status1 |
Terminated 3 on July 06, 2012 |
| Recall Number | Z-3104-2011 |
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| Recall Event ID |
59567 |
| 510(K)Number | K042975 K050186 K053175 K063015 |
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| Product Classification |
Alcohol dehydrogenase, specific reagent for ethanol enzyme method - Product Code DIC
|
| Product | Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013.
Following Cup and Dip product models involved in the recall:
40900
40901
30500-A
30575 -A
30603-A
30671-A
30800-A
30802-3A
30900-A
30950-A
31102-A
40901C
60410-3A
60500-A
60505-A
60524-A
60526-A
60535-A
60600-A
60602-4A
60630-A
60635-4A
60640-4A
60705-4A
60709-A
60800-6A
60800-A
60801-A
60820-A
60903-A
60910-A
60921-A
60925-A
60930-A
61020-A
61023-A
61026-4A
61028-3A
61030-3A
61044-6A
61052-4A
61100-A
61204-A
61206-4A
61206-6A
61303-A
61401-A
61404-A
65500-4A
70410-4A
70500-3A
70500-A
70550-A
70602-3A
70604-6A
70630-3A
70640-4A
70808-6A
70910-A
In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine. |
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| Code Information |
ITEM CODE LOT # 40900 A900 061610 40901 A901 042310 40901 A901 050310 40901 A901 070610 40901 A901 081710 40901 A901C 072110 40901 A904 042310 30500-A A500 022610 30500-A A500 062910 30575 -A A575 040110 30575-A A575 010510 30575-A A575 040110 30575-A A575 081110 30575-A A575 092010 30575-A A575 122309 30603-A A603 100810 30671-A A671 052410 30671-A A671 091310 30800-A A800 030810 30800-A A800 061610 30800-A A800 080310 30800-A A800 082510 30800-A A800 090210 30802-3A 3A802 033010 30802-3A 3A802 051310 30802-3A 3A802 063010 30802-3A 3A802 073010 30802-3A 3A802 082310 30900-A A900 032310 30900-A A900 051310 30900-A A900 060810 30900-A A900 061610 30900-A A900 071410 30900-A A900 072810 30900-A A900 082410 30900-A A900 100510 30900-A A900 101210 30904-A A904 051710 30950-A A950 052209 30950-A A950 062910 30950-A A950 072110 31102-A A1402 051110 40901C A901C 030310 40901C A901C 051310 40901C A901C 072110 40901C A901C 082310 60410-3A 3A410 040710 60500-A A500 030310 60500-A A500 052810 60500-A A500 060810 60500-A A500 062910 60500-A A500 070910 60500-A A500 092210 60505-A A505 052010 60505-A A505 062910 60524-A A524 112309 60526-A A526 062310 60535-A A535 022310 60535-A A535 070210 60535-A A535 090210 60600-A A600 040110 60600-A A600 050710 60600-A A600 071210 60600-A A600 081310 60602-4A 4A602 042810 60602-4A 4A602 050510 60630-4A 4A630 051110 60630-A A630 080510 60630-A A630 092210 60635-4A 4A635 061610 60640-4A 4A640 041510 60640-4A 4A640 062210 60640-4A 4A640 072110 60640-A A640 071609 60705-4A 4A705 060410 60705-4A 4A705 100510 60709-A A709 120809 60800-6A 6A800 091610 60800-A A800 022610 60800-A A800 060310 60800-A A800 080910 60800-A A800 092210 60801-A A801 062110 60820-A A800 072310 60820-A A820 060110 60820-A A820 062310 60820-A A820 072310 60820-A A820 100510 60903-A A903 052810 60910-A A910 071210 60910-A A910 100610 60921-A A921 100710 60925-A A925 030110 60925-A A925 060110 60925-A A925 080610 60930-A A930 060710 60930-A A930 081110 61020-A A020 032310 61020-A A020 061610 61020-A A020 081310 61023-A A023 051110 61023-A A023 100110 61026-4A 4A026 030310 61026-4A 4A026 090210 61028-3A 3A028 080210 61030-3A 3A030 071210 61030-3A 3A030 081110 61030-3A 3A030 101410 61044-6A 6A044 072810 61052-4A 4A052 072810 61052-4A 4A052 091010 61100-A A100 051310 61100-A A100 062310 61100-A A100 073010 61100-A A100 082510 61204-A A204 050310 61204-A A204 061010 61204-A A204 061610 61204-A A204 092310 61206-4A 4A206 012810 61206-4A 4A206 083010 61206-6A 6A206 051110 61303-A A303 052010 61401-A A401 062110 61401-A A401 070610 61404-A A401 062110 65500-4A 4A500 030510 65500-4A 4A500 050310 65500-4A 4A500 060710 65500-4A 4A500 061510 65500-4A 4A500 062510 65500-4A 4A500 070910 65500-4A 4A500 072810 65500-4A 4A500 100110 70410-4A 4A410 082510 70500-3A 3A500 071610 70500-3A 3A500 091310 70500-A A500 060810 70500-A A500 072610 70500-A A500 092810 70550-A A550 072610 70602-3A 3A602 072310 70602-3A 3A602 080510 70604-6A 6A604 082310 70630-3A 3A630 072910 70640-4A 4A640 071609 70808-6A 6A808 081310 70808-6A 6A808 082610 70910-A A910 082310 70910-A A910 082610 |
Recalling Firm/
Manufacturer |
Express Diagnostics Int'l., Inc.
1550 Industrial Dr
Blue Earth MN 56013-1100
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| For Additional Information Contact |
507-526-3951 |
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Manufacturer Reason
for Recall | Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product was not 510 K cleared for in vitro diagnostic use and could not be labeled as such in the US. |
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FDA Determined
Cause 2 | Error in labeling |
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| Action | Express Diagnostics Intl., Inc. sent an Updated Recall Notice dated November 1, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have open orders of the affected product to contact customer service about their order. Customers were asked to complete and fax the form on page 3 of the document to 507-526-2252.
Further shipment of products could not continue until Express Diagnostics received the signed form.
For questions regarding this recall call 507-526-3951. |
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| Quantity in Commerce | 56,650 |
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| Distribution | Nationwide Distribution including AZ, CA,K CT, FL, GA, IL, IA, LA, MD, MA, MN, MS, MO,K MT, NE, NJ, NY, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. |
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| 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 = DIC
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