Z-2330-2015Class II

S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The...

Name: Z-2330-2015 S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The...
Creator: Roche Diagnostics Operations, Inc.
Published: 2015-06-24
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2015-06-24 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2015-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2330-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-08-05
Terminated: 2016-01-12
Recalling firm: Roche Diagnostics GmbH
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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2330-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2330-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05

Product code CHL

K032311Class IIRoche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. / cleared 2003-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)