Z-0473-2013Class II

Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully...

Name: Z-0473-2013 Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully...
Creator: Roche Diagnostics Operations, Inc.
Published: 2012-11-01
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2012-11-01 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis on 2012-11-01. FDA classified it as Class II and gives the reason as "On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent...". 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-0473-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-01
Posted: 2012-12-04
Terminated: 2014-01-08
Recalling firm: Roche Diagnostics GmbH
Product: Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (C
Root cause tag: software
FDA root cause: Software design
Action: On 11/01/2012 an "Urgent Medical Device Correction" notification was sent via UPS Ground (receipt required) to consignees. The device issue was described and recommended actions were provided. A Roche Field Application Specialist will install the new e-barcode during a scheduled visit. Customers also will have an option to install the new e-barcodes themselves, following the instructions provided in the notification. A Software update will be released when available. Customers may contact Technical Support at 1-800-428-2336 for more information.
Quantity in commerce: 78 analyzers
Distribution: Nationwide Distribution, including the states of AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, NJ, NY, OH, VA, WA, and WI.
Product codes and lots: Catalog numbers affected: Alkaline Phosphatase acc. to IFCC Gen.2 05166888190; Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate (P5P) activation 05850797190; Bicarbonate Liquid 05446376190; Creatinine Jaff¿ Gen.2 05168597190; C-Reactive Protein Gen.3 05172373190; and Urea/BUN 05171873190. Serial Number(s): 0917-10, 1020-04, 1020-05, 1021-03, 1021-04, 1021-07, 1021-08, 1023-06, 1023-09, 1023-10, 1024-03, 1024-04, 1024-05, 1024-09, 1025-02, 1025-05, 1025-07, 1025-09, 1026-01, 1026-02, 1027-09, 1028-01, 1028-07, 1030-09, 1031-05, 1031-09, 1032-09, 1032-10, 1033-04, 1033-05, 1107-06, 1109-02, 1109-03, 1111-07, 1111-08, 1112-02, 1112-04, 1115-06, 1115-07, 1115-08, 1115-10, 1117-04, 1117-07, 1118-02, 1126-02, 1126-03, 1126-04, 1127-01, 1127-02, 1127-06, 1127-07, 1138-03, 1138-04, 1139-04, 1139-05, 1139-06, 1140-02, 1140-03, 1140-04, 1140-05, 1140-10, 1141-08, 1141-09, 1142-02, 1142-03, 1142-04, 1143-01, 1143-02, 1143-03, 1143-04, 1143-05, 1143-06, 1144-05, 1146-04, 1146-05, 1146-06, 1146-07, and 1146-08.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0473-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0473-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)