FDA Device Intelligence
Home › Beckman Coulter, Inc. › Synchron

Synchron

Beckman Coulter, Inc. · Model 442765 · UDI-DI 15099590625719

CJW Prescription
10
510(k) clearances
17
Adverse events
1
Recalls
24
Facilities

Description

Albumin Reagent (ALB 2 x 300)

Recalls

DateFirmReason
2019-03-18Roche Diagnostics CorporationThe reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.

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 docs
Data 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.