Recall Z-0913-2020 ยท KQO Automated Urinalysis System
Beckman Coulter Inc.
iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips.
| Date | Oct 28, 2019 |
| Status | Terminated |
| Reason | Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics). |
| Root cause | Software in the Use Environment |
| Action | An Urgent Medical Device Recall letter was sent during the week of 10/28/2019 to the affected customers via mail and e-mail. The notice stated the misidentification issue as follows: Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics)." The following actions were provided to reduce the potential for this issue until a software update is available: - Follow good laboratory practice (GLP) and ensure that a unique identific |
| Quantity | 4314 devices |
| Distribution | Worldwide distributions. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT Iris International Inc., A Division of Iris Iris I, Mar 23, 2011 |