# FDA recall Z-2557-2018

> **Roche Diagnostics Hematology** · Class II · device recall initiated 2018-05-07.

## 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.

## 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).

## 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.

## Key facts

- **Recall number:** Z-2557-2018
- **Recalling firm:** Roche Diagnostics Hematology
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-07
- **Report date:** 2018-08-01
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2557-2018

## Citation

> AI Analytics. FDA recall Z-2557-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2557-2018. Source: US FDA. Licensed CC0.

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