Reported Jun 3, 2020 · Ongoing
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of…
Abbott GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Gmbh & Co. KG · Max-Planck-Ring 2 · Wiesbaden, N/A · N/A
Is this the product you have?
- ARCHITECT
- iGentamicin Reagent Kit - Product UsageThe measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy
- Lot codes and dates
- MODEL1P31-25
- LOT NUMBERS
04281BE0008510BE00
- and 11221BE00 Shelf life per LOT
04281BE002020-MAY-21 08510BE002020-AUG-08 11221BE002020-NOV-18
- Amount recalled
- 6087 Reagent Kits
Where it was sold
Why it was recalled
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 the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.
This product could cause temporary or reversible health problems — stop using it.
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