Home › Roche Diagnostics GmbH › AlbuminBCP AlbuminBCP
AlbuminBCP AlbuminBCP
Roche Diagnostics GmbH · Model 11815148216 · UDI-DI 04015630990634
CJW
Prescription
1
510(k) clearances
17
Adverse events
1
Recalls
24
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-03-18 | Roche Diagnostics Corporation | The 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 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.