Z-2557-2018Class II

cobas m 511 integrated hematology analyzer, Model Number 07261691190

Name: Z-2557-2018 cobas m 511 integrated hematology analyzer, Model Number 07261691190
Creator: Roche Diagnostics Hematology
Published: 2018-05-07
License: https://open.fda.gov/license/

Roche Diagnostics Hematology, Inc. / initiated 2018-05-07 / Terminated / root cause: software

FDA source

Roche Diagnostics Hematology began a recall of cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated... on 2018-05-07. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2557-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-07
Posted: 2018-07-26
Terminated: 2020-05-12
Recalling firm: Roche Diagnostics Hematology, Inc.
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.
Product code: JOY Device, Automated Cell-Locating
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).
Root cause tag: software
FDA root cause: 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.
Product codes and lots: All systems with software version 1.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2557-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2557-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-26

Product code JOY

K171655Class IIcobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc. / cleared 2018-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)