Food, drugs, devices › Beckman Coulter Inc.
Device recall: UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Beckman Coulter Inc. (Brea, CA) initiated this device recall on 3 Nov 2017; FDA lists 3 product records under event 78611, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 19 Jun 2018. 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
"The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position."
Distribution
"CA, AR, HI, CA, OH, WA, MD, Canada, Japan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0236-2018 | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer | 15 units | Class II | Terminated | 20 Dec 2017 |
| Z-0237-2018 | UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities) | 1 unit | Class II | Terminated | 20 Dec 2017 |
| Z-0238-2018 | UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer | 3 units | Class II | Terminated | 20 Dec 2017 |
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: "The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "CA, AR, HI, CA, OH, WA, MD, Canada, Japan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Jun 2018. "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.