Roche Diagnostics Operations, Inc.: 48 recalls on record

Recalls filed with 1 agency: FDA (48).

First recall on record: December 12, 2012. Most recent: November 27, 2024.

Risk classification: Class II: 45 · Class III: 3

Most recent recalls

DateAgencyProduct
September 10, 2014FDARoche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to sto…Z-2563-2014
June 25, 2014FDAcobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat.…Z-1791-2014
June 25, 2014FDARoche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-…Z-1790-2014
June 25, 2014FDAcobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat.…Z-1792-2014
May 21, 2014FDAACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count…Z-1616-2014
April 16, 2014FDACobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chem…Z-1449-2014
April 9, 2014FDAOmni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Num…Z-1315-2014
December 25, 2013FDAMagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automa…Z-0536-2014
December 4, 2013FDAACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)…Z-0385-2014
November 13, 2013FDACOBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001,…Z-0168-2014
September 4, 2013FDAACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood gl…Z-2109-2013
July 24, 2013FDAB-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the i…Z-1727-2013
July 3, 2013FDACoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthca…Z-1583-2013
July 3, 2013FDACoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS…Z-1581-2013
July 3, 2013FDACoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional …Z-1584-2013
July 3, 2013FDACoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguC…Z-1582-2013
May 29, 2013FDACobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the …Z-1368-2013
April 24, 2013FDAACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the A…Z-1113-2013
April 24, 2013FDACoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the Co…Z-1114-2013
April 10, 2013FDARoche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 052327…Z-1028-2013
January 30, 2013FDARoche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.Z-0696-2013
December 19, 2012FDACobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole …Z-0522-2013
December 12, 2012FDACobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 800…Z-0473-2013

Questions about this company

How many recalls does Roche Diagnostics Operations, Inc. have?
Recalert has 48 U.S. recalls on record for Roche Diagnostics Operations, Inc., published between December 12, 2012 and November 27, 2024.
Which agencies have handled Roche Diagnostics Operations, Inc. recalls?
Roche Diagnostics Operations, Inc. appears as the recalling firm in recalls from: FDA (48).

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