Z-1610-2018Class II

cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S...

Name: Z-1610-2018 cobas b 221 Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S...
Creator: Roche Diagnostics Corporation
Published: 2018-02-22
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-02-22 / Terminated / root cause: software

FDA source

Roche Diagnostics Corporation began a recall of cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer... on 2018-02-22. FDA classified it as Class II and gives the reason as "The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate". 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-1610-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-22
Posted: 2018-05-03
Terminated: 2019-11-15
Recalling firm: Roche Diagnostics GmbH
Product: cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 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, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Root cause tag: software
FDA root cause: Software design
Action: ROCHE sent an Urgent Medical Device Correction Letter dated February 22, 2018, via UPS to affected customers. Customers were instructed to complete the following: " 1) Use the Return to Setup and Exit buttons to ensure execution of scheduled AutoQC measurements as described in this Urgent Medical Device Correction (UMDC); 2) Check to see if the next scheduled AutoQC measurement is performed to ensure the AutoQC scheduler is working as expected; 3) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site; 4) Complete the attached fax form (TP-00146) and fax it to 1-844-491-7776 or scan and email to [email protected]; 5) File this UMDC for future reference. Customers with questions should contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.
Quantity in commerce: 1026 total products
Distribution: USA ( nationwide)
Product codes and lots: 3337111001 and 3337111692 UDI: 04015630018307

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1610-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1610-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1611-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1612-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1613-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03

Product code CEM

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)