FDA Device recall Z-1311-2018
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA…
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA… by Roche Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1311-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-22 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | CA, FL, IN |
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
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.
Identifiers
| code_info | Elecsys BRAHMS PCT: 07301715190 Lot number 204084 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1311-2018%22
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