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Beckman Coulter, Inc. · Model OSR6006 · UDI-DI 15099590000035
CIW
Prescription
1
510(k) clearances
0
Adverse events
5
Recalls
7
Facilities
Description
α-Amylase
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-11 | Ortho-Clinical Diagnostics | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifi |
| 2020-05-11 | Ortho-Clinical Diagnostics | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifi |
| 2020-05-11 | Ortho-Clinical Diagnostics | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifi |
| 2020-05-11 | Ortho-Clinical Diagnostics | Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifi |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.