Recall Z-1752-2020 ยท DJG Enzyme Immunoassay, Opiates
Beckman Coulter Inc.
Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
| Date | Apr 20, 2020 (initiated Sep 4, 2019) |
| Status | Terminated |
| Reason | Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results. |
| Root cause | Material/Component Contamination |
| Action | An Urgent Medical Device Recall Letter was sent to customers via either U.S. postal service or email beginning on 9-4-2019. The letter informs customers that studies indicate that cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP) and Opiate 2000 ng (OP2) Instructions For Use (IFU). This letter included the Instructions for Use (IFU) claims versus study results for each product. Customers were informed of which compounds (at specific concentrations or ranges) may result in false positive or false negative test results. The letter indicated that Laboratories s |
| Quantity | 7,951 units |
| Distribution | Distributed throughout the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031002 | SYNCHRON SYSTEMS OPIATE REAGENT Beckman Coulter, Inc., Apr 29, 2003 |