FDAJune 29, 2017device
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
030221090010302310997303739040001037390406920502357200105023599001047459220010474592269205036348001050363486920586065200105990378001
Recall history
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