Elecsys Troponin I Immunoassay: Catalog# 05094810160 - 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 Immunoassay kits (Catalog# 05094810160) used to aid in diagnosing heart attacks. The recall was initiated because of a confirmed issue where running the proBNP II test immediately before the Troponin I test on cobas e 601 and 602 laboratory modules can cause decreased recovery of Troponin I results, potentially leading to false negative results. This issue affects 726 kits that were distributed nationwide across 28 states.
The source record does not specify what actions affected consumers or healthcare facilities should take 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: 726 kits Lot/code info: UDI: 04015630939374
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.