Z-0522-2013Class II

Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro...

Name: Z-0522-2013 Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro...
Creator: Roche Diagnostics Operations, Inc.
Published: 2012-11-14
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2012-11-14 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+... on 2012-11-14. FDA classified it as Class II and gives the reason as "It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0522-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-14
Posted: 2012-12-13
Terminated: 2013-08-07
Recalling firm: Roche Diagnostics GmbH
Product: Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Roche sent an Urgent Medical Device Removal (UMDR12-268) notification and faxback form on November 14, 2012, to all affected consignees. Customers were requested to discontinue the use of cobas b 123 Fluid Pack COOX, 200 lots 21426121 and21426171 and discard the product per local regulations. Customers were instructed to use the enclosed faxback form to order replacement product at 1-800-722-7222. For questions customers were instructed to contact Roche Diagnostics Technical Support at 1-800-526-2272. For questions regarding this recall call 317-521-3966.
Quantity in commerce: 23 units of Fluid Pack COOX, 200 were distributed
Distribution: Nationwide Distribution including NE and AZ.
Product codes and lots: Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0522-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0522-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-13

Product code CHL

K111188Class IICobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus BRoche Diagnostics / cleared 2012-05-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)