Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 11, 2026
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter, Inc. recalled COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isot… - a moderate-severity action.
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isot… was recalled by Beckman Coulter, Inc. in February 11, 2026. Reason: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with …. Check the official notice for the remedy. Verify recall #Z-1221-2026 with the FDA Devices before acting.
The recall
Beckman Coulter, Inc. issued this moderate-severity FDA Devices recall-Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with ….
- Moderate
- severity level
- 76K units
- affected scope
- Class II
- classification
- February 11, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1221-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1221-2026) was formally reported on February 11, 2026, with the manufacturer initiating the action on November 10, 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 76,098 units (US-61843 and OUS-14255).
The documented reason for this recall is: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto …. 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
76,098 units (US-61843 and OUS-14255)
Related Recalls
6
3 from same agency
Product description
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.
Reason for recall
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1221-2026 |
| Date reported | February 11, 2026 |
| Date initiated | November 10, 2025 |
| Recalling firm | Beckman Coulter, Inc. |
| Firm location | Miami, FL |
| Affected scope | 76,098 units (US-61843 and OUS-14255) |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto Rico, RI, SC, SD, TN… |
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-1221-2026) 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? ▼
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.. Recalled by Beckman Coulter, Inc.. Units affected: 76,098 units (US-61843 and OUS-14255).
Why was this product recalled? ▼
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1221-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1221-2026) 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 February 11, 2026. 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.