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Sirrus® Albumin LiquiColor®
STANBIO LABORATORY, L.P. · Model S0285-750 · UDI-DI 00657498001516
DCF
Prescription
10
510(k) clearances
64
Adverse events
3
Recalls
40
Facilities
Description
For the quantitative determination of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-10-14 | Ortho Clinical Diagnostics Inc | Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 |
| 2017-04-24 | Beckman Coulter Inc. | Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. |
| 2013-04-30 | Wako Life Sciences, Inc. | Product fails to meet the accuracy at the low end of the measuring range. |
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