Drug recall
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and…
FDA recall event 85590 · Class II · Abbott Gmbh & Co. KG
Key facts
| Event ID | 85590 |
|---|---|
| Recall numbers | Z-2117-2020 |
| Recalling firm | Abbott Gmbh & Co. KG |
| Product type | Devices |
| Products | ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after… |
| Initiation date | Apr 24, 2020 |
| Report date | Jun 3, 2020 |
| City | Wiesbaden |
| Country | Germany |
| FEI number | 3002809144 |
At a glance
- 1–9 Products in this recall
- 1–9 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: