Class I Recall of Beckman Coulter Life Sciences DxH800 and DxH600 and DxH 900 Hematology Analyzers
Beckman Coulter is recalling the DxH 800, DxH 600, and DxH 900 Hematology Analyzers due to sporadic erroneously elevated platelet count results without flags or system messages, meaning there is no way for the laboratory operator of the test to recognize the error. Inaccurate platelet counts may cause serious adverse health consequences such as increased risk for life-threatening bleeding associated with withholding platelet transfusion or inappropriate decisions for surgeries or invasive procedures; delayed or missed diagnosis of serious medical conditions, including thrombotic microangiopathy and heparin induced thrombocytopenia.
The US Food and Drug Administration (FDA) is not aware of serious adverse events that have been directly linked to the hematology analyzers.
Recalled Product Information:
- Recalled Product: UniCel DxH 800 Coulter Cellular Analysis System, UniCel DxH 600 Coulter Cellular Analysis System, and UniCel DxH 900 Coulter Cellular Analysis System
- Product Catalog/Reference Numbers (Part numbers for device models):B23858, C11478, 629029, B24465, B24802, B68304, B66445, B63322
- Distribution Dates: January 2008 to present (DxH 800 and DxH 600); April 2018 to present (DxH 900)
- Manufacturing Dates: January 2008 to present (DxH 800 and DxH 600); April 2018 to present (DxH 900)
- Devices Recalled in the U.S.: 3428
On May 20, 2019, Beckman Coulter notified customers of an updated Urgent Medical Device Recall letter which replaces the initial notification letter dated July 30, 2018. In this letter, customers are advised to:
- Share the letter with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have transferred any of the affected product(s) listed above to other laboratories, please provide them with a copy of the letter.
- Confirm receipt of letter to Beckman Coulter Customer Support within 10 days by:
- Electronically, if you received this communication through email.
- Manually, complete and return the Response Form.
Actions for Running Samples:
- Run samples on an instrument not subject to this recall to confirm the platelet results
- If an alternative instrument is not available, use the following quality control measures to aid in identification of discrepant platelet results:
- Perform manual scanning or estimate of platelets on a peripheral smear and compare with instrument results. Note that this method will identify samples with marked to moderate thrombocytopenia but may not identify smaller discrepancies.
- Repeat testing of samples in a workflow configuration may facilitate the identification of discrepancies. If an erroneous result is detected, review results from adjacent samples, such as those tested on the instrument both before and after the erroneous result.
- Additional instrument or LIS features including reference ranges, XM (exponentially-weighted moving average) and delta checks may be informative.
- Follow your laboratory’s standard operating procedure to confirm unexpected results.
- Ongoing investigation indicates that sweep flow disruption may occur following the “Clear RBC Apertures” procedure. This potential root cause is currently under further investigation. Customers should discontinue using this procedure. If you suspect that your instrument has a clogged aperture that will not clear, discontinue use of the analyzer, contact Beckman Coulter Customer Support Center and request service.
- Communicate to the ordering physicians the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features. Physicians should be vigilant when reviewing platelet count results, particularly in patients at risk for thrombocytopenia, such as those with leukemia, certain types of anemia, infection, alcohol abuse, autoimmune diseases, thrombotic microangiopathy, hypersplenism, pregnant patients, patients on chemotherapy, receiving heparin treatment or taking certain medication including quinine, anticonvulsants and sulfonamide antibiotics.
- Consult with your Medical Director to determine if a retrospective review of results is warranted.
- Report any unflagged erroneously elevated platelet counts experienced in your laboratory to Beckman Coulter and the FDA.
See the recall notice for additional information.
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