Food, drugs, devices › Beckman Coulter Inc.
Device recall: UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SM
Beckman Coulter Inc. (Brea, CA) initiated this device recall on 4 Aug 2016; FDA lists 1 product record under event 74875, 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 6 Oct 2016. 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
"Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire."
Distribution
"Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2692-2016 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a… | 759 units total (358 units in US) | Class II | Terminated | 7 Sep 2016 |
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: "Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire."
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: "Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Oct 2016. "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.