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Microalbuminuria Kit (Immunoturbidimetric Method)
Medicalsystem Biotechnology Co., Ltd. · Model None · UDI-DI 06970291985222
10
510(k) clearances
65
Adverse events
3
Recalls
39
Facilities
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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