Reported Sep 11, 2019 · Terminated
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers :…
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 8000 Modular Analyzer Seriescobas 8000
- ISE module part Numbers05964075001
- cobas c 701 module part Numbers05641489001
- cobas c 702 module part Numbers06473245001
- Lot codes and dates
- cobas c 701 module Serial # : 19P2-01, 1390-03, 1139-04, 1139-05, 1139-06. cobas c 702 module serial # : 1126-03, 1237-10, 14C2-04 cobas¿ 8000 ISE module serial # : 1943-01, 1943-02, 1943-03, 1943-04, 1943-05, 1943-06, 1943-07, 1943-08, 1943-09, 1943-10, 15B3-05.
- Amount recalled
- 19 units
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
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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