Recall Z-3113-2011 ยท JXN Enzyme Immunoassay, Propoxyphene
Express Diagnostics Int'l., Inc.
DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 6072
| Date | Aug 31, 2011 (initiated Oct 4, 2010) |
| Status | Terminated |
| Reason | Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as "forensic use only", meaning they cannot be distributed or used for treatment or diagnostic purposed in the United States. |
| Root cause | Labeling False and Misleading |
| Action | The firm, Express Diagnostics Int'l, Inc., sent a "RECALL NOTICE" letter dated October 4, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to notify their customers of the labeling change, and complete and return the DISTRIBUTOR/CUSTOMER CONFIRMATION FORM via fax to Express Diagnostics Int'l, Inc., at 1-507-526-2252. The letter also noted that "Further shipment of product containing BUP and/or PPX cannot continue until Express Diagnostics Int'l, Inc. receives the signed form." If you have any questions, call 507-526-395 |
| Quantity | 196,750 |
| Distribution | Nationwide distribution:AZ, CA, CT, GA, MD, MA, MN, MO, NH, NJ, OR, SC, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.