Recall Z-2557-2018 ยท JOY Device, Automated Cell-Locating
Roche Diagnostics Hematology
cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA anticoagulated whole blood. It utilizes computer
| Date | May 7, 2018 |
| Status | Terminated |
| Reason | Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and the following parameters are affected: RBC (red blood cell count), HGB (hemoglobin concentration), MCH (mean corpuscular hemoglobin), HCT (hematocrit), and MCV (mean corpuscular volume). |
| Root cause | Software design |
| Action | An Urgent Field Safety Notice was distributed to customers via email on 5/7/18. The notification included the following actions for to be taken by the customer/user: Until this rule is implemented, when cobas m 511 integrated hematology analyzer displays a HGB value of less than or equal to 9g/dL, Roche advises the user to not report results for the RBC, HGB, MCH, HCT, and MCV parameters. Roche advises the user to perform laboratory confirmatory testing before making transfusion decisions. Delta check against previous results might additionally be used to evaluate the results. For custome |
| Quantity | 17 |
| Distribution | No distribution in the United States. The devices were distributed to the following foreign countries: Austria, France, Germany, Hong Kong, Japan, Netherlands, Pakistan, Singapore, South Korea, Switzerland, Thailand, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171655 | cobas m 511 integrated hematology analyzer Roche Diagnostics Hematology, Inc., Mar 2, 2018 |