FDA recall Z-1311-2018

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.

Distribution

US Distribution in states of: CA, FL and IN.

Key facts

Status

Terminated

Initiation date

2017-12-22

Report date

2018-04-11

Termination date

2019-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1311-2018