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 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 parameters: RBC, 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.
Recall
- Recall Number
- Z-2557-2018
- Event Number
- 80376
- Firm
- Roche Diagnostics Hematology
- FEI Number
- 3012792398
- Product Code
- JOY
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 7, 2018
- Terminated
- May 12, 2020
- Address
- 69 Milk St, Ste 120, Westborough, MA, 01581-1227
Description
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 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 parameters: RBC, 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.
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).
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 customer evaluating the instrument Roche kindly advises to not report values for diagnostic use until the rule is configured by your Roche Application Specialist.
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.
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