Roche recalls cobas m 511 hematology analyzers that may give inaccurate results for patients with severe microcytic anemia, including iron deficiency and thalassemia. Affected units may need recalibration or software update.
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).
Roche is recalling cobas m 511 hematology analyzers that can give incorrect blood test results for patients with severe microcytic anemia. This could lead to misdiagnosis and improper treatment if the analyzer is used without correction.
The analyzer may produce inaccurate results for specific blood parameters in patients with severe microcytic anemia. This could lead to misdiagnosis and incorrect treatment decisions if the device is used without proper correction.
Patients with severe microcytic anemia (such as iron deficiency or thalassemia) who use the cobas m 511 hematology analyzer for blood tests. Laboratory staff using the device may also be affected.
Check for the model number 07261691190 on the cobas m 511 integrated hematology analyzer. The device was sold with software version 1.0.
Reach out to Roche Diagnostics for guidance on whether your device needs recalibration or software update.
No, the recall specifically affects results for patients with severe microcytic anemia, such as iron deficiency or thalassemia.
Look for the model number 07261691190 and software version 1.0 on the cobas m 511 integrated hematology analyzer.
Contact Roche Diagnostics for instructions on whether recalibration or software update is needed.
We’ve drafted a message you can send Roche Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2557-2018 — Roche Diagnostics Roche Diagnostics Hello, I own a Roche Diagnostics that is covered by recall Z-2557-2018 from Roche Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
