Home › Beckman Coulter, Inc. › CC T1-RD1 (CD5-RD1)
CC T1-RD1 (CD5-RD1)
Beckman Coulter, Inc. · Model 6603020 · UDI-DI 15099590542016
GKZ
Prescription
10
510(k) clearances
23,439
Adverse events (17 deaths)
244
Recalls
63
Facilities
Description
COULTER CLONE T1-RD1
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.