Reported Aug 1, 2018 · Terminated
cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated…
Roche Diagnostics Hematology
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Hematology · 69 Milk St Ste 120 · Westborough, MA · 01581-1227
Is this the product you have?
- cobas m 511 integrated hematology analyzer
- Model Number 07261691190 Product UsageThe 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 imaging to count the formed elements of blood and provide an image-based assessment of cell morphology, which may be reviewed by the operator, and also allows for manual classification of unclassified cells. The instrument
- reports the following parametersRBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, %NRBC, #NRBC, WBC, %NEUT, #NEUT, %LYMPH, #LYMPH, %MONO, #MONO, %EO, #EO, %BASO, #BASO, PLT, MPV, %RET, #RET, HGB-RET
- Lot codes and dates
- All systems with software version 1.0
- Amount recalled
- 17
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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