Z-1595-2021Class II

Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 -

Name: Z-1595-2021 Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 -
Creator: Roche Diagnostics Operations, Inc.
Published: 2021-04-07
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2021-04-07 / Open, Classified / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction on 2021-04-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1595-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-07
Posted: 2021-05-14
Recalling firm: Roche Diagnostics GmbH
Product: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Product code: MMI Immunoassay Method, Troponin Subunit
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 10, 489 kits
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.
Product codes and lots: UDI: 04015630939381

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1595-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1595-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-14
Z-1596-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-26	2021-05-14

Product code MMI

K082699Class IIElecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics / cleared 2009-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)