cobas m 511 integrated hematology analyzer recall
cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative…
Why was cobas m 511 integrated hematology analyzer 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All systems with software version 1.0
- Product
- cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative…
- Recalling firm
- Roche Diagnostics Hematology
- 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.
- Recall date
- August 1, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)