Recall Z-1595-2021
Roche Diagnostics Operations, Inc. · initiated April 7, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Codes / lots: UDI: 04015630939381
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1595-2021
- Initiated
- April 7, 2021
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Quantity
- 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.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1596-2021 Class II | Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in…Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an… | 04/07/2021Open, Classified |