The Recall Desk

Manufacturer

Roche Diagnostics Hematology

1 recall in our database name Roche Diagnostics Hematology as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2018-08-01

Of the 1 recalls from Roche Diagnostics Hematology we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-2557-2018·2018-08-01

    Roche Recalls cobas m 511 Hematology Analyzer for Discrepant Results

    Roche Diagnostics Hematology is recalling 17 cobas m 511 integrated hematology analyzers due to discrepant results in patients with severe microcytic anemia.

    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 clin
    Category
    Medical Device
    Distribution
    0 states