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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67058

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 08, 2013
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

4 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 4

UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Z-1828-2014
Recall number
Z-1828-2014
Initiated
November 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
2,874 units total (1696 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

Code information

All serial numbers

Distribution pattern

Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

device · product 2 of 4

UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Z-1829-2014
Recall number
Z-1829-2014
Initiated
November 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
164 units total (106 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

Code information

All serial numbers

Distribution pattern

Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

device · product 3 of 4

Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.

Z-1830-2014
Recall number
Z-1830-2014
Initiated
November 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
768 units total (6 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

Code information

Lot No. 3040200 3056140 3071360

Distribution pattern

Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

device · product 4 of 4

Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.

Z-1831-2014
Recall number
Z-1831-2014
Initiated
November 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
12,924 units total (9,733 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

Code information

Lot No. 3040210 3040330 3043090 3043100 3057970 3057980 3058130 3071440 3071450

Distribution pattern

Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.