Recall Z-3104-2011
Express Diagnostics Int'l., Inc. · initiated November 1, 2010
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.
Codes / lots: 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…
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.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-3104-2011
- Initiated
- November 1, 2010
- Posted by FDA
- August 31, 2011
- Terminated
- July 6, 2012
- Product code
- DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Quantity
- 56,650
- 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.
- Recalling firm
- Express Diagnostics Int'l., Inc., Blue Earth, MN