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Medonic M-series
Boule Medical AB · Model M16 US · UDI-DI 07350040796344
1
510(k) clearances
23,441
Adverse events (17 deaths)
244
Recalls
63
Facilities
Description
A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-18 | Abbott Laboratories | Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. |
| 2025-08-13 | Beckman Coulter Inc. | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
| 2025-08-13 | Beckman Coulter Inc. | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
| 2025-08-13 | Beckman Coulter Inc. | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
| 2025-08-13 | Beckman Coulter Inc. | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. |
| 2025-07-08 | Becton, Dickinson and Company, BD Bio Sciences | Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. |
| 2025-07-08 | Becton, Dickinson and Company, BD Bio Sciences | Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. |
| 2025-06-03 | Becton, Dickinson and Company, BD Bio Sciences | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples |
| 2025-06-03 | Becton, Dickinson and Company, BD Bio Sciences | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples |
| 2025-03-18 | Abbott Laboratories | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.