CLASS II ONGOING Device recall · Reported 26 May 2021 · FDA Enforcement Report
Elecsys Troponin I Immunoassay recalled by Roche Diagnostics Operations
Roche Diagnostics Operations is recalling Elecsys Troponin I Immunoassay, distributed nationwide in the US. The recall was initiated on 7 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1596-2021
- FDA event ID
- 87705
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Apr 2021
- FDA classified
- 14 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Apr 2021 | Recall initiated by company | |
| 14 May 2021 | Classified by FDA | +37 days |
| 26 May 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaConnecticutFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyMarylandMaineMissouriNorth CarolinaNebraskaNew JerseyNew MexicoNew YorkOhio
Questions about this recall
Why was it 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.
Which lots are affected?
UDI: 04015630939374
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87705This product is part of a recall event; the main page for the event is Elecsys Troponin I STAT Immunoassay recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Elecsys Troponin I STAT Immunoassay recalled | Roche Diagnostics Operations | Potency & Assay | Nationwide |
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