Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 29, 2019
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Th
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Inc. recalled UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: No… - a critical-severity action.
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: No… was recalled by Beckman Coulter Inc. in May 29, 2019. Reason: Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Throm…. Check the official notice for the remedy. Verify recall #Z-1383-2019 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this critical-severity FDA Devices recall-Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Throm….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- May 29, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1383-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1383-2019) was formally reported on May 29, 2019, with the manufacturer initiating the action on July 30, 2018. It is classified under Critical severity (Class I), 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 2,059 devices.
The documented reason for this recall is: Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China, Croatia, Egypt, F…. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,059 devices
Related Recalls
6
3 from same agency
Product description
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC
Reason for recall
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1383-2019 |
| Date reported | May 29, 2019 |
| Date initiated | July 30, 2018 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 2,059 devices |
| Distribution | Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China, Croatia, Egypt, France, Germany, Gree… |
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-1383-2019) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC. Recalled by Beckman Coulter Inc.. Units affected: 2,059 devices.
Why was this product recalled? ▼
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Critical. Recall number: Z-1383-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China, Croatia, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lithuania, Mexico, Morocco, Myanmar, Netherlands Antilles, New Zealand, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Trinidad and Tobago, U.A.E, United Kingdom, and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1383-2019) 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 May 29, 2019. 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.