Medical device recalls Moderate risk

Roche Diagnostics Operations, Inc. recalls cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

Recall date
July 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2476-2019
FDA classification
Class II
Brand / firm
Roche Diagnostics Operations, Inc.
Sold / distributed
State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK

Why it was recalled

Quality issue with high pressure solenoid valves may cause inaccurate results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

Get recall alerts

Free email alert whenever Roche Diagnostics Operations, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Roche Diagnostics Operations, Inc.