Recall Z-3104-2011 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Express Diagnostics Int'l., Inc.
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-
| Date | Aug 31, 2011 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II Ameditech, Inc., Dec 29, 2004 |
| K050186 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III Ameditech, Inc., Mar 4, 2005 |
| K053175 | AMEDITECH DRUGSMARTCUP Ameditech, Inc., Dec 8, 2005 |
| K063015 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 Ameditech, Inc., Dec 20, 2006 |