Abbott recalls ARCHITECT iGentamicin Reagent Kit (model 1P31-25) due to possible inaccurate test results when used with certain troponin tests. Affected lots: 04281BE00 (until May 2020), 08510BE00 (until Aug 2020), 11221BE00 (until Nov 2020).
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.
Abbott is recalling its ARCHITECT iGentamicin Reagent Kit (model 1P31-25) because it may cause inaccurate test results when used with specific troponin tests. This could lead to incorrect diagnoses or treatment decisions for patients. The recall affects certain lots manufactured in 2020.
The reagent kit may interact with certain troponin tests when processed immediately after the gentamicin test. This interaction could lead to inaccurate measurements that might affect treatment decisions for patients with potential heart issues.
Healthcare professionals using the ARCHITECT iGentamicin Reagent Kit for gentamicin monitoring may be affected. Patients receiving treatment based on inaccurate test results could be at risk.
Check the lot number on the kit: 04281BE00 (valid until May 2020), 08510BE00 (valid until August 2020), or 11221BE00 (valid until November 2020). The product model is 1P31-25.
Look for the lot number on the reagent kit: 04281BE00, 08510BE00, or 11221BE00.
The model number is 1P31-25.
Affected lot numbers are 04281BE00 (valid until May 2020), 08510BE00 (valid until August 2020), and 11221BE00 (valid until November 2020).
Inaccurate test results could lead to incorrect diagnoses or treatment decisions for patients with potential heart issues.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2117-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2117-2020 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
