Severity
Moderate
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.
Reported: November 13, 2013 Initiated: September 24, 2013 #Z-0147-2014 1,025 units units
Beckman Coulter Inc. issued this FDA Devices recall on November 13, 2013. Classified as Moderate severity (Class II). Approximately 1,025 units units are affected. The recall was issued because: Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 6…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0147-2014) was formally reported on November 13, 2013, with the manufacturer initiating the action on September 24, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records indicate 1,025 units units are affected.
The documented reason for this recall is: 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 indicat… Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
1,025 units
Related Recalls
6
6 from same agency
Product Description
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.
Reason for Recall
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
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 1,025 units
- Distribution
- Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Trindad and Tobago, Turkey, United Arab Emirates, and United Kingdom. .
- Location
- Brea, CA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0147-2014 |
| Date reported | November 13, 2013 |
| Date initiated | September 24, 2013 |
| Recalling firm | Beckman Coulter Inc. |
| Units affected | 1,025 units |
| Distribution | Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Beckman Coulter Inc.. Units affected: 1,025 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2013. Severity: Moderate. Recall number: Z-0147-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Trindad and Tobago, Turkey, United Arab Emirates, and United Kingdom. ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0147-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
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- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
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Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
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All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).