S2 Fluid Pack on the Cobas b 221 system recall
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…
Why was S2 Fluid Pack on the Cobas b 221 system recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 19 affected devices of lot 21450781 were distributed in the US.
- Distribution
- US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.
- Recall date
- August 12, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)