Lower riskMedical device recall · FDA · Published April 7, 2021
Roche Elecsys Troponin I STAT Assay Recall: Possible False Negatives in Heart Tests
Roche recalls Elecsys Troponin I STAT Immunoassay (Catalog# 05094798160) due to possible false negatives in heart attack tests when used with specific analyzers. Affected units may not detect heart attacks correctly.
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.
“Roche Elecsys Troponin I STAT Assay Recall: Possible False Negatives in Heart Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62833-roche-elecsys-troponin-i-stat-assay-recall-possible-false-negatives. Based on FDA recall #Z-1595-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1595-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled Elecsys Troponin I STAT Immunoassay kits on April 7, 2021, due to possible sporadic false negative conventional troponin results, the FDA said. Owners should contact Roche for a remedy.
How to tell if you have it
Brand: Roche
Product: Elecsys Troponin I STAT Immunoassay
Catalog#: 05094798160
UDI: 04015630939381
The hazard
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.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Other recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Roche cobas HCYS Assay Recall (Oct. 17, 2024).
How to tell if you have this one
Check for the catalog number 05094798160 on the test kit. The product is used with cobas e 601 or 602 analyzers for heart attack testing.
Brand
Roche
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Quantity
Z-1595-2021
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.; UDI: 04015630939381
10, 489 kits
Z-1596-2021
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.; UDI: 04015630939374
726 kits
Based on the official FDA remedy
What to do — step by step
Check Kit Catalog Number
Look for the catalog number 05094798160 on the test kit label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 28 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wyoming.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall indicates a potential risk of missing a heart attack diagnosis, but the hazard level is low risk as it only affects test accuracy in specific lab conditions.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1595-2021 (April 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1595-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.