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ADAM-rWBC Kit
NanoEnTek, Inc. · Model ADHK-050 · UDI-DI 08809317541006
GKZ
Prescription
10
510(k) clearances
23,449
Adverse events (17 deaths)
244
Recalls
63
Facilities
Description
It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC HT.
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.