Z-0752-2021Class II

cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

Name: Z-0752-2021 cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-11-23
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-11-23 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use on 2020-11-23. FDA classified it as Class II and gives the reason as "During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0752-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-23
Posted: 2020-12-29
Terminated: 2023-07-06
Recalling firm: Roche Diagnostics GmbH
Product: cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
Root cause tag: design
FDA root cause: Device Design
Action: On 11/20/2020, Roche issued Urgent Medical Device Correction notices to customers via phone and fax. Customers were advised to do the following: A Roche Customer Support Center representative will contact the four affected customers by phone and a copy of UMDC TP-01155 will be faxed to the customer. Any customer questions or concerns will be addressed during the phone call.
Quantity in commerce: 152 kits and 7 units
Distribution: Domestic: IL, FL, GA, WV
Product codes and lots: Catalog Number 08445605190 08445567190 08253153190 08058580190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0752-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0752-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29

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)