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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 641–660 of 970 recalls

Roche Diagnostics Corp.: Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianap...

The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.

FDAApr 22, 2009Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche cobas 6000 analyzer series (including cobas c 501 a...

Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware.

FDAApr 1, 2009Nationwide• Roche Diagnostics Corp.

Diagnostic Chemicals, Ltd.: DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagen...

Labeled with extended expiration date (24 months instead of 18 months)

FDA

1...31 323334 35...49

Page 33 of 49Next

Feb 12, 2009

Nationwide

• Diagnostic Chemicals, Ltd.

Roche Diagnostics Corp.: Roche MagNA Pure LC Workstation; Product Numbers: 1223693...

Laceration Risk

Protruding screw threads may cut the user when cleaning the interior of the instrument.

FDAFeb 9, 2009Nationwide• Roche Diagnostics Corp.

Diagnostic Hybrids Inc: Rabbit Kidney Culture, brand name: 'FreshCells'. The pr...

During QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells).

FDAJan 21, 2009Nationwide• Diagnostic Hybrids Inc

Siemens Medical Solutions Diagnostics: Immulite 2000 and Immulite 2500 digital Fluidics PC Board...

Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.

FDAJan 5, 2009AZ, CA, FL +12 more• Siemens Medical Solutions Diagnostics

Roche Diagnostics Corp.: Roche COBAS c 111 Analyzer with ISE module option, GMMI N...

Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty valves is that they may not open or close properly which can disturb the fluid transportation within the ISE module resulting in problems with ISE calibration, con

FDANov 17, 2008Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi Modular Analytics System, clinical chemistr...

If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.

FDANov 12, 2008Nationwide• Roche Diagnostics Corp.

BD Diagnostics (GeneOhm Sciences, Inc): BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 R...

BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.

FDANov 11, 2008CA, IL, IN +15 more• BD Diagnostics (GeneOhm Sciences, Inc)

Diagnostica Stago, Inc.: STA Neoplastine CI Plus 10; Product Catalogue Number: 066...

Internal investigation has determined the potential lack of homogeneity between product vials.

FDAOct 20, 2008Nationwide• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA Neoplastine CI 10; Product Catalogue Number: 0666; Ma...

Internal investigation has determined the potential lack of homogeneity between product vials.

FDAOct 20, 2008Nationwide• Diagnostica Stago, Inc.

Siemens Healthcare Diagnostics, Inc: ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Ca...

Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias

FDAOct 3, 2008Nationwide• Siemens Healthcare Diagnostics, Inc

Bd Diagnostic Systems Tripath: BD PrepStain System, Model Number: 799-14000-00; Catalog ...

Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.

FDASep 26, 2008Nationwide• Bd Diagnostic Systems Tripath

Trek Diagnostic Systems: HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnos...

Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.

FDASep 22, 2008IL, IN, OH• Trek Diagnostic Systems

Roche Diagnostics Corp.: Roche ISE Internal Standard Gen.2 for use on Roche cobas ...

Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.

FDASep 15, 2008Nationwide• Roche Diagnostics Corp.

Sonosite, Inc.: SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer...

The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array.

FDAAug 8, 2008Nationwide• Sonosite, Inc.

Immunodiagnostics Systems Inc: IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the qu...

A small number of customers have experienced low absorbance values when using kits from this batch.

FDAAug 2, 2008Nationwide• Immunodiagnostics Systems Inc

BD Diagnostics (GeneOhm Sciences, Inc): BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay...

BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant Staphylococcus aureus. The potential health hazard related to a false positive result from this assay would be that a patient may be misclassified as having MRSA colonization when in fact they do not have

FDAJul 21, 2008Nationwide• BD Diagnostics (GeneOhm Sciences, Inc)

Siemens Medical Solutions Diagnostics: IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vi...

Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 - 20 ng/mL as opposed to approximately 3% at 1-3 ng/mL - for more detail see the bias plot that is included with this notice.).

FDAJul 21, 2008PR• Siemens Medical Solutions Diagnostics

BD Diagnostics (GeneOhm Sciences, Inc): BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay i...

FDAJul 21, 2008Nationwide• BD Diagnostics (GeneOhm Sciences, Inc)