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Roche Diagnostics Corp.

Roche Diagnostics Corp. Recalls

All product recalls associated with Roche Diagnostics Corp..

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 721–740 of 970 recalls

Roche Diagnostics Corp.: Roche Online TDM Tobramycin, for use on Roche/Hitachi ana...

Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.

FDAApr 5, 2007Nationwide• Roche Diagnostics Corp.

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: Abbott AxSYM System Digoxin III Reagent Pack

Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.

FDAMar 30, 2007PR• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Diagnostica Stago, Inc.: STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. i...

Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.

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FDAMar 30, 2007Nationwide• Diagnostica Stago, Inc.

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 -...

Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.

FDAMar 20, 2007AR, CA, CO +33 more• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Roche Diagnostics Corp.: Roche COBAS Integra DIG, Digoxin Reagent for use on the C...

The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.

FDAMar 16, 2007Nationwide• Roche Diagnostics Corp.

Diagnostica Stago, Inc.: STA Liatest VWF:Ag, Product Catalog Number : 0518. This...

A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.

FDAMar 13, 2007Nationwide• Diagnostica Stago, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Cata...

Tests exhibit falsely elevated results.

FDAMar 2, 2007Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Corp.: CoaguChek brand PT Test Strips; U.S. Catalog Number 31162...

The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.

FDAFeb 28, 2007Nationwide• Roche Diagnostics Corp.

American Diagnostica, Inc.: American Diagnostica Inc. ACTICLOT dPT Reference 824 i...

Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas

FDAFeb 28, 2007Nationwide• American Diagnostica, Inc.

Inverness Medical Professional Diagnostics: Clearview Simplify D-dimer, in vitro diagnostic for quali...

Laceration Risk

Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.

FDAFeb 15, 2007PR• Inverness Medical Professional Diagnostics

Sonosite, Inc.: MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasoun...

Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.

FDAFeb 5, 2007OH, TN• Sonosite, Inc.

Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom: VITROS Immunodiagnostics Products HBsAg Reagent Pack, Ca...

Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.

FDAFeb 1, 2007PR• Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom

Diagnostica Stago, Inc.: STA Compact and STA Compact CT For in vitro Diagnostic Us...

Fire/Burn Risk

Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.

FDAJan 18, 2007Nationwide• Diagnostica Stago, Inc.

Siemens Medical Solutions Diagnostics: Sample Management System software for in vitro diagnostic...

Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.

FDAJan 15, 2007Nationwide• Siemens Medical Solutions Diagnostics

Roche Diagnostics Corp.: Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric)...

Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 700 and 800 analyzers and the R1 reagent of the Tina-quant Hemoglobin A1c assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 800 analyzer.

FDADec 15, 2006Nationwide• Roche Diagnostics Corp.

Diagnostic Chemicals, Ltd.: Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot N...

Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories

FDADec 5, 2006PA• Diagnostic Chemicals, Ltd.

Siemens Healthcare Diagnostics: ADVIA Centaur CP System, Catalog/Part Number 086-A001. A...

Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after 4 days after installation onto the Centaur CP system due to evaporation.

FDANov 9, 2006Nationwide• Siemens Healthcare Diagnostics

Roche Diagnostics Corp.: CoaguChek brand PT Test Strips; U.S. Catalog Number 31162...

Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.

FDAOct 18, 2006Nationwide• Roche Diagnostics Corp.

Ortho-Clinical Diagnostics: VITROS Chemistry Products LIPA Slides GEN 48, Coating 32...

The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for more than 2 days.

FDAOct 9, 2006Nationwide• Ortho-Clinical Diagnostics

Inverness Medical Professional Diagnostics: NOW Legionella Urinary Antigen Test. 22 test kit. For I...

Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches

FDASep 29, 2006Nationwide• Inverness Medical Professional Diagnostics