Recall Z-0914-2020 ยท LKM Counter, Urine Particle
Beckman Coulter Inc.
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.
| 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 | 6601 devices |
| Distribution | Worldwide distributions. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022774 | IQ 200 SYSTEM Intl. Remote Imaging Systems, Oct 21, 2002 |