Reported Apr 10, 2019 · Ongoing
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system…
Beckman Coulter 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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line
- System Name/ Catalog Number
DxC 660i/ A64871DxC 680i /A64903DxC 860i /A64935DxC 880i /A59102
- Lot codes and dates
- Systems running software versions
5.25.3.05.3.1
- Systems running software versions
- Amount recalled
- 0
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
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Beckman Coulter Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.