Recall events
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Event 78611
Event summary
Timeline bucket November 03, 2017
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Beckman Coulter Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
3 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Z-0236-2018
Recall number Z-0236-2018
Initiated November 03, 2017
Classification Class II
Status Terminated
Quantity 15 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0236-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45642]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Code information Serial Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151
Distribution pattern CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[25252]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
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)
Z-0237-2018
Recall number Z-0237-2018
Initiated November 03, 2017
Classification Class II
Status Terminated
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0237-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51347]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Code information Serial Number AZ06682
Distribution pattern CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[25712]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
Z-0238-2018
Recall number Z-0238-2018
Initiated November 03, 2017
Classification Class II
Status Terminated
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0238-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21430]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Code information Serial Numbers: AW09034, AV40142, AU19113
Distribution pattern CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20274]
FDA event record
· Exact recall-number query on openFDA
