Roche Diagnostics Corporation: Medical Device Recall in 2018 - (Recall #: Z-1611-2018)

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:

Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.

Product Classification:

Class II

Date Initiated: February 22, 2018

Date Posted: May 9, 2018

Recall Number: Z-1611-2018

Event ID: 79676

Reason for Recall:

The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.

Status: Terminated

Product Quantity: 1026 total products

Code Information:

Catalog numbers: 3337138001 and 3337138692 UDI: 04015630018321

Distribution Pattern:

USA ( nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated