Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling Elecsys Troponin I STAT Immunoassay kits (Catalog# 05094798160) used to aid in the diagnosis of heart attacks. The company identified a technical issue where running the proBNP II test immediately before the Troponin I test on cobas e 601 and 602 analyzer modules can result in falsely low troponin readings. This could cause some test results to appear negative when they should be positive, potentially missing cases of myocardial infarction. The recall affects 10,489 kits distributed nationwide across 28 states.
The recalled product has UDI 04015630939381. The source record does not specify a remedy or what consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.
Reason for recall: Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed. Distribution: US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, ID, IL, IN,KS, KY, MD, ME, MO, NC, NE, NJ, NM, NY, OH, OK, SC, SD, TN, TX, VA, WA, WY. Quantity: 10, 489 kits Lot/code info: UDI: 04015630939381
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.