Roche Diagnostics Operations, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1595-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 7, 2021

Date Posted: May 26, 2021

Recall Number: Z-1595-2021

Event ID: 87705

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.

Status: Ongoing

Product Quantity: 10, 489 kits

Code Information:

UDI: 04015630939381

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.

Voluntary or Mandated:

Voluntary: Firm initiated