FDADecember 18, 2017device

Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

UPCs

037390406920302310900105023599001050235720010373904000103023109973

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973. — Recall Details · AllClear