The Recall Desk

Manufacturer

Roche Diagnostics Operations, Inc.

127 recalls in our database name Roche Diagnostics Operations, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
127
Critical
0
Severe
19
Most recent
2026-03-11

Of the 127 recalls from Roche Diagnostics Operations, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (15%) 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.

126–127 of 127

  • ModerateFDA (Devices)·Z-0522-2013·2012-12-19

    Roche Recalls Cobas b 123 Fluid Pack Cuvettes Due to Thickness Defect

    Roche Diagnostics is recalling specific lots of Cobas b 123 Fluid Pack COOX cuvettes because a production error caused a change in layer thickness, leading to a higher failure rate.

    Product
    Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2013·2012-12-12

    Roche Recalls 78 Cobas 8000 Analyzers Due to Reagent Pipetting Defect

    Roche Diagnostics is recalling 78 Cobas 8000 Modular Analyzers because a probe positioning mismatch can cause insufficient reagent pipetting, potentially affecting test results.

    Product
    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide