—#186809

Product

Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K082699
Affected lot / code info: UDI: 04015630939381

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

On 04/07/2021, Roche issued Urgent Medical Device Correction via fax notifying customers that 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 was measured immediately before the Troponin I analyte on the same module, a decreased recovery of Troponin I was observed.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-04-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.