[Recalled] Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical l
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood C |
|---|---|
| Brand / manufacturer | Beckman Coulter Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0021-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 April 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Beckman Coulter Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
- Laptop and Computer Allergy-Free Options for Sensitive Users
- What is 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonic acid (CAS 375-73-5)? Safety, Regulation & EU/US/Canada Perspective | ProductGuru
- Clothing and Apparel Brands to Avoid in 2024: What You Need to Know
- Cheapest Products for Food (Folder)/Fish and Seafood (Fol Online)
- What is the botanas category? Top brands, safety considerations, EU + US labeling regimes | ProductGuru
- Books Buying Guide: How to Choose the Right Book for You