Reported Nov 13, 2013 · Terminated
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative,…
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 DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.
- Lot codes and dates
- Part Numbers629029 for DxH 800 and B23858 for DxH 600
- Serial Numbers
1,024 of 1,024 codes
AS49437AV11229AV23436AV28032AT05062AU32435AT27373AT09132AV06132AV06143AT21266AT21268AT23307AS46410AS46411AU48003AV05097AT27346AT40554AU23277AV05082AV05092AV11205AT06076AT09112AT09114AT16214AT18235AV11214AV11217AN30069AS07008AT09116AS40361AU05048AU05054AT48658AS49426AS49429AV01023AV01025AM48043AV06003AT40542AS15064AT30380AV01015AS12050AV06004AV06151AS12051AS12052AT01004AU25303AT36497AT36499AT36509AV06127AV06130AV11231
- Amount recalled
- 1,025 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb
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.