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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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