Home › Beckman Coulter, Inc. › Synchron
Synchron
Beckman Coulter, Inc. · Model 475100 · UDI-DI 15099590225339
DCF
Prescription
10
510(k) clearances
64
Adverse events
3
Recalls
39
Facilities
Description
Microalbumin Reagent (MA 2 x 100)
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.