Reported Sep 11, 2019 · Terminated
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas e 601 module (cobas 6000
- Modular Series system) Part Number04745922001
- Lot codes and dates
- Serial # : 31A1-01
- Amount recalled
- 1 unit
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Quality issue with high pressure solenoid valves may cause inaccurate results.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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