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U.S. Department of Health and Human Services

Class 2 Device Recall cobas m 511 integrated hematology analyzer

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  Class 2 Device Recall cobas m 511 integrated hematology analyzer see related information
Date Initiated by Firm May 07, 2018
Create Date July 26, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-2557-2018
Recall Event ID 80376
510(K)Number K171655  
Product Classification Device, automated cell-locating - Product Code JOY
Product 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.
Code Information All systems with software version 1.0
Recalling Firm/
Manufacturer		 Roche Diagnostics Hematology
69 Milk St Ste 120
Westborough MA 01581-1227
Manufacturer Reason
for Recall		 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).
FDA Determined
Cause 2		 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 customer evaluating the instrument Roche kindly advises to not report values for diagnostic use until the rule is configured by your Roche Application Specialist.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JOY and Original Applicant = Roche Diagnostics Hematology, Inc.
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