Recall Z-1311-2018— Roche Diagnostics Corporation

Name: FDA recall Z-1311-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-22

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2017-12-22, terminated 2019-04-05. It names one FDA 510(k) clearance: K160729. 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..

Recalling firm: Roche Diagnostics Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-22
Terminated: 2019-04-05
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K160729 — Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics·cleared 2016-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.