Recall Z-1596-2021— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-1596-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-07

Class II · Ongoing

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2021-04-07. It names one FDA 510(k) clearance: K082699. Product: Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.. Reason: 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..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-04-07
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K082699 — ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMSRoche Diagnostics·cleared 2009-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.