CLASS I Device recall · Reported 29 May 2019 · FDA Enforcement Report
UniCel DxH 800 Coulter Cellular Analysis System recalled
Beckman Coulter is recalling UniCel DxH 800 Coulter Cellular Analysis System, distributed nationwide in the US. The recall was initiated on 30 Jul 2018 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1382-2019
- FDA event ID
- 82329
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Jul 2018
- FDA classified
- 23 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 30 Jul 2018 | Recall initiated by company | |
| 23 May 2019 | Classified by FDA | +297 days |
| 29 May 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
Product as listed by the FDA
UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC
Where it was distributed
Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China, Croatia, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lithuania, Mexico, Morocco, Myanmar, Netherlands Antilles, New Zealand, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Trinidad and Tobago, U.A.E, United Kingdom, and Vietnam.
Questions about this recall
Is UniCel DxH 800 Coulter Cellular Analysis System recalled?
Yes. Beckman Coulter recalled UniCel DxH 800 Coulter Cellular Analysis System on 30 Jul 2018. The recall is Class I and its status is Terminated. Recall number Z-1382-2019.
Why was it recalled?
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
Which lots are affected?
All current software versions are impacted
Where was it sold?
Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China, Croatia, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lithuania, Mexico, Morocco, Myanmar, Netherlands Antilles, New Zealand, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Trinidad and Tobago, U.A.E, United Kingdom, and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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