Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination Recalled by Roche Diagnostics Corporation Due to Product exhibits a decreased recovery of patient samples...

Date: December 22, 2017
Company: Roche Diagnostics Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Corporation directly.

Affected Products

Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).

Quantity: 47

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 3 states: CA, FL, IN

Affected (3 states)Not affected

About Roche Diagnostics Corporation

Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report