The Recall Desk
ModerateFDA (Devices)·Z-2330-2015·Announced 2015-08-12

Roche Cobas b 221 S2 Fluid Pack Recall for Transponder Error

Roche is recalling S2 Fluid Packs for the Cobas b 221 system because they may generate a transponder error, preventing the instrument from starting measurements.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional error (transponder error) that prevents the device from operating, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling S2 Fluid Packs used with the Cobas b 221 Blood Gas and Electrolytes Analyzer. The affected fluid packs may generate a transponder error when loaded onto the system. This error prevents the fluid from being recognized by the system, and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.

A total of 19 affected devices from lot 21450781 were distributed in the United States. The distribution included Connecticut, Texas, Louisiana, North Dakota, Michigan, New Jersey, Ohio, Oklahoma, Puerto Rico, South Carolina, and Kentucky. The recall also lists lot numbers 21450887 and 21451391 with expiration dates in 2016.

Healthcare facilities should stop using the affected S2 Fluid Packs and contact Roche Diagnostics for replacement or further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
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 calci
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 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

Distributed in 11 states:

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