Home › FUJIFILM WAKO PURE CHEMICAL CORPORATION › HR Series NEFA-HR(2) Color Reagent A
HR Series NEFA-HR(2) Color Reagent A
FUJIFILM WAKO PURE CHEMICAL CORPORATION · Model 999-34691 · UDI-DI 14987481164601
JLH
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
6
Facilities
Description
In-Vitro Diagnostic Use
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-10 | Randox Laboratories Ltd. | Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient |
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