Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 5, 2025
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter, Inc. recalled CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior… - a moderate-severity action.
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior… was recalled by Beckman Coulter, Inc. in November 5, 2025. Reason: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instru…. Check the official notice for the remedy. Verify recall #Z-0412-2026 with the FDA Devices before acting.
The recall
Beckman Coulter, Inc. issued this moderate-severity FDA Devices recall-Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instru….
- Moderate
- severity level
- 108 units
- affected scope
- Class II
- classification
- November 5, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0412-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0412-2026) was formally reported on November 5, 2025, with the manufacturer initiating the action on September 8, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter, Inc. is listed as the recalling firm, operating out of Miami, FL. Federal records list the affected scope as 108 units.
The documented reason for this recall is: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, … Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong…. 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
108 units
Related Recalls
6
3 from same agency
Product description
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Reason for recall
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0412-2026 |
| Date reported | November 5, 2025 |
| Date initiated | September 8, 2025 |
| Recalling firm | Beckman Coulter, Inc. |
| Firm location | Miami, FL |
| Affected scope | 108 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Jap… |
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-0412-2026) 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? ▼
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.. Recalled by Beckman Coulter, Inc.. Units affected: 108 units.
Why was this product recalled? ▼
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0412-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Portugal, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0412-2026) 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 November 5, 2025. 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.