Reported Apr 19, 2017 · Terminated
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Roche Diagnostics Corporation
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 Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
- Lot codes and dates
- Cobas 8100 bi-directional reformatter (BRF) module with
- Software Version 02-xx Catalog Number743995400
- Amount recalled
- 45 Units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
"Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over."
This product could cause temporary or reversible health problems — stop using it.
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