Roche Diagnostics Operations, Inc.: 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

Is my product affected?

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, hematocri

• UPC 03260925184

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. is recalling S2 Fluid Packs (Catalog Number 03260925184) used with Cobas b 221 blood gas and electrolytes analyzers. The affected fluid packs may generate a transponder error when loaded onto the system, preventing the fluid from being recognized and stopping the instrument from starting measurements. The recall affects three lot numbers (21450781, 21450887, and 21451391) with expiration dates between August and September 2016, with 19 affected devices distributed across Connecticut, Texas, Louisiana, North Dakota, Michigan, New Jersey, Ohio, Oklahoma, Puerto Rico, South Carolina, and Kentucky.

The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY. Quantity: 19 affected devices of lot 21450781 were distributed in the US. Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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