Drug recall
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
FDA recall event 84612 · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Event ID | 84612 |
|---|---|
| Recall numbers | Z-1230-2020, Z-1231-2020, Z-1232-2020, Z-1233-2020 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Product type | Devices |
| Products | ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869, Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533, Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520, Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe… |
| Initiation date | Dec 18, 2019 |
| Report date | Feb 26, 2020 |
| Termination date | Jun 25, 2020 |
| City | Tarrytown |
| State | NY |
| Country | United States |
| FEI number | 2432235 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: