Device product

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

Z-1269-2018

December 18, 2017

Class II

Product summary

Firm: Roche Diagnostics Corporation
Event: Event 79074
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-1269-2018

Official wording

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

Code information: None

Distribution pattern: US Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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