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BECKMAN COULTER IRELAND INC. · Model OSR6167 · UDI-DI 15099590010645
DCF
Prescription
1
510(k) clearances
64
Adverse events
3
Recalls
40
Facilities
Description
MICROALBUMIN
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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