Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative… — Class II medical device recall Z-1311-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-04-11, distributed in CA, FL, IN. Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANA
| Recall number | Z-1311-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-12-22 |
| Classified | 2018-04-04 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2019-04-05 |
| Distributed | CA, FL, IN |
| Quantity | 47 |
| Lot numbers | 204084 |
Product
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Reason for recall
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1311-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.