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Beckman Coulter, Inc. · Model ODR3022 · UDI-DI 15099590080778
JHN
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
9
Facilities
Description
APO A1 & B Calibrator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-23 | Beckman Coulter Ireland, Inc. | The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B pat |
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