Roche Diagnostics Operations, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2330-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; 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, bilirubin, 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: June 24, 2015

Date Posted: August 12, 2015

Recall Number: Z-2330-2015

Event ID: 71609

Reason for Recall:

The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.

Status: Terminated

Product Quantity: 19 affected devices of lot 21450781 were distributed in the US.

Code Information:

Catalog Number: 03260925184; Lot Numbers & Exp. Dates: 1. 21450781, Exp. 08/31/2016 2. 21450887, Exp. 08/31/2016 3. 21451391, Exp. 09/30/2016

Distribution Pattern:

US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.

Voluntary or Mandated:

Voluntary: Firm initiated