Roche Modular E 170 Analyzer Recalled for Questionable Results
Roche Diagnostics is recalling Modular E 170 Analyzers because using 13 mm sample tubes without adapters may cause questionable test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves questionable results rather than direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Roche Diagnostics Corporation is recalling the Modular E 170 Analyzer, an immunoassay chemistry analyzer used for clinical purposes. The recall affects specific catalog numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001, and 03023109973.
The recall was initiated after complaints were received regarding questionable results on the analyzers. These issues occurred when customers utilized 13 mm sample tubes without the required tube adapters. The distribution pattern for the affected units is listed as US Nationwide.
Healthcare facilities and users of these analyzers should stop using the affected equipment and contact Roche Diagnostics Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- None
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Roche Diagnostics Corporation
See all →- ModerateRoche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination
FDA (Devices) · 2019-07-24
- LowRoche cobas p 701 Post-Analytical Units Recalled for Loose Flap
FDA (Devices) · 2019-07-10
- LowRoche cobas p 501 Post-Analytical Units Recalled for Loose Flap
FDA (Devices) · 2019-07-10
- HighRoche Cobas infinity Software Recall for Missing Quality Control Alarms
FDA (Devices) · 2019-05-29
- SevereRoche Recalls cobas e 801 Immunoassay Analyzers Due to Signal Drops
FDA (Devices) · 2019-05-08
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06