Roche Diagnostics Corporation: Medical Device Recall in 2018 - (Recall #: Z-1311-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: December 22, 2017

Date Posted: April 11, 2018

Recall Number: Z-1311-2018

Event ID: 79462

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.

Status: Terminated

Product Quantity: 47

Code Information:

Elecsys BRAHMS PCT: 07301715190 Lot number 204084

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated