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APO B
RANDOX LABORATORIES LIMITED · Model LP3839 · UDI-DI 05055273204469
JHN
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
9
Facilities
Description
An APO B test system is a device intended for the quantitative in vitro determination of Apolipoprotein B (APO B) in serum and plasma.
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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