Recall Z-2387-2011 ยท DJG Enzyme Immunoassay, Opiates
Express Diagnostics Int'l., Inc.
DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Earth MN 56013 USA, Model numbers : 70801-4(NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR, Lot 4-801 102910, Exp APR 2012, & Lot 4-801 112210, Exp MAY 2012, Export Only); 65500-4A (AMP-COC--OP1-TCH-MET-ALC-pH,SG-NI,CR, Lot 4A-500 110310, Exp MAY 2012, For forensic use only); 30705 ( DI
| Date | May 27, 2011 (initiated Mar 18, 2011) |
| Status | Terminated |
| Reason | Express Diagnostics Int'l, Inc. has initiated a medical device recall on various model numbers of DrugCheck devices, This recall was due to incorrect product expiration dating after findings from an FDA inspection. Use of expired product may not work properly, and may give incorrect screening results. |
| Root cause | Incorrect or no expiration date |
| Action | The firm, Express Diagnostic Int'l, Inc., sent an "Urgent Recall of DrugCheck Product" letter dated April 19, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine the product; notify Express Diagnostic of the quantity even if no product is remaining; complete and return the DISTRIBUTOR/CUSTOMER RECALL CONFIRMATION FROM via fax to 1-507-526-2252 as soon as possible. In addition, if they have further distributed the product to identify their customers and notify them of the recall. Provided procedures |
| Quantity | 6925 devices |
| Distribution | Worldwide distribution: USA (nationwide) including states of: FL, IA, MD, OK, and WA; and countries including: AUSTRALIA and ITALY. |
| 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 |