FDA Devices recall · Reported December 18, 2013
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids
Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood ce…
Beckman Coulter Inc. recalled Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coul… - a moderate-severity action.
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coul… was recalled by Beckman Coulter Inc. in December 18, 2013. Reason: Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may pot…. Check the official notice for the remedy. Verify recall #Z-0470-2014 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this moderate-severity FDA Devices recall-Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may pot….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- December 18, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0470-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids
Reason for recall
Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0470-2014 |
| Date reported | December 18, 2013 |
| Date initiated | November 8, 2013 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 4155 units total (1676 units in US) |
| Distribution | Worldwide Distribtion - USA Nationwide including the countries of Algeria, Andorra, Angola, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Bulgaria, China, Colombia, Croatia, Czech Republic, Ecuador, Egy… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0470-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026