Food, drugs, devices › Beckman Coulter Inc.
Device recall: UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product
FDA enforcement event 82329 is a device recall by Beckman Coulter Inc. of Brea, CA, initiated 30 Jul 2018 and classified Class I, with 3 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 31 Mar 2022. Initiation: voluntary: firm initiated. Beckman Coulter Inc. has 216 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Beckman Coulter Inc., Brea, CA.
Reason for recall
"Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized."
Distribution
"Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1382-2019 | 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… | 5,414 devices | Class I | Terminated | 29 May 2019 |
| Z-1383-2019 | UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel… | 2,059 devices | Class I | Terminated | 29 May 2019 |
| Z-1384-2019 | UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s guidance, Guidance for Industry and FDA… | 341 | Class I | Terminated | 29 May 2019 |
Context
Other enforcement events for Beckman Coulter Inc.
All 216 events for Beckman Coulter Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Mar 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.