Z-0755-2021Class II

Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry...

Name: Z-0755-2021 Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry...
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-12-08
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-12-08 / Open, Classified / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use... on 2020-12-08. FDA classified it as Class II and gives the reason as "Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0755-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-08
Posted: 2020-12-30
Recalling firm: Roche Diagnostics GmbH
Product: Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
Root cause tag: software
FDA root cause: Software design
Action: Roche recall issued Urgent Medical Device Correction (UMDC TP-01165 and UMDC TP-01169) notifications on 12/8/2020 via UPS Ground (receipt required). Both UMDCs will also be posted to the diagnostics.roche.com website. Letter states reason for recall, health risk and action to take: Consignee Instructions: Inform any operators who use the cobas 8000 modular analyzer series or the cobas pro integrated solutions of the potential hazards associated with this issue and provide a copy of the UMDC notification, as appropriate. Follow the actions outlined in the Customer Actions to Determine if the Issue Has Occurred section of the UMDC. Confirm that you have backed up your most recent settings. Repeat this maintenance function whenever a system setting is changed. Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Complete the enclosed faxback form and return it following the instructions on the form. File this UMDC for future reference. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in commerce: 7 units
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0755-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0754-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-06	2020-12-30
Z-0755-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-06	2020-12-30

Product code JJE

K191899Class IIGlucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche Diagnostics / cleared 2019-08-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)