FDA Medical Device Recalls (openFDA)
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 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.
- Recall number
- Z-2330-2015
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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 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.
- Status
- Terminated
- Initiated
- 2015-06-24
- Posted
- 2015-08-05
- Terminated
- 2016-01-12
- Reason
- 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.
- Root cause
- Process control
- Action
- Roche Diagnostics sent an Urgent Medical Device Correction dated July 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to do the following: 1. Keep in the inventory a backup S2 Fluid Packs from an unaffected lot, or at least four additional S2 Fluid Packs from the affected lots when product from unaffected lots is not available. 2. If the S2 Fluid Pack generates a Transponder error message, contact the Roche Support Network Customer Support Center at 1-800-526-2272 (provide the lot and serial number printed on the side of the affected S2 Fluid Pack). 3. After contacting Roche Support Network Customer Support Center, dispose of the affected S2 Fluid Pack per local guidelines. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272, if you have questions about the information contained in this Urgent Medical Device Correction.
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K032311"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28