Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 17, 2012
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYT…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Inc. recalled CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows s… - a moderate-severity action.
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows s… was recalled by Beckman Coulter Inc. in October 17, 2012. Reason: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stabili…. Check the official notice for the remedy. Verify recall #Z-0033-2013 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this moderate-severity FDA Devices recall-The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stabili….
- Moderate
- severity level
- 137K units
- affected scope
- Class II
- classification
- October 17, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0033-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0033-2013) was formally reported on October 17, 2012, with the manufacturer initiating the action on May 22, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 137,445 units total (26,155 units in US), a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-E… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colo…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
137,445 units total (26,155 units in US)
Related Recalls
6
3 from same agency
Product description
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Reason for recall
The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0033-2013 |
| Date reported | October 17, 2012 |
| Date initiated | May 22, 2012 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 137,445 units total (26,155 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech… |
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-0033-2013) 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.
Frequently Asked Questions
What product was recalled? ▼
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.. Recalled by Beckman Coulter Inc.. Units affected: 137,445 units total (26,155 units in US).
Why was this product recalled? ▼
The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2012. Severity: Moderate. Recall number: Z-0033-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador El Salvador Finland France French Guiana French Polynesia Germany Greece Guadeloupe Hong Kong India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea, Republic of Kuwait Libyan Arab Jamahiriya Lithuania Macao Malaysia Mexico Monaco Morocco Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sudan Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Uruguay.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0033-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 17, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.