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BD Diagnostics (GeneOhm Sciences, Inc)

BD Diagnostics (GeneOhm Sciences, Inc) Recalls

All product recalls associated with BD Diagnostics (GeneOhm Sciences, Inc).

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Recall Summary

Total Recalls

1000

Past Year

304

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 4321–4340 of 4747 recalls

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)

Advanced Medical Optics, Inc.: AMO Healon D Ophthalmic Viscosurgical Device, Product Cod...

Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery.

FDAOct 29, 2008Nationwide• Advanced Medical Optics, 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.

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FDAOct 20, 2008Nationwide• Diagnostica Stago, 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.

Spectranetics Corporation: Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012,...

Catheter pouch was mislabeled with the wrong size.

FDAOct 15, 2008CA, FL, MI +6 more• Spectranetics Corporation

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.

Philips Healthcare Informatics, Inc.: iSite PACS (Picture Archiving and Communication System), ...

Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot

FDAAug 29, 2008CO, MN, PA• Philips Healthcare Informatics, 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)

Synaptic Corp: Synaptic 3600 and 3800 with Cranial Electrical Stimulatio...

Device was distributed without marketing approval.

FDAJul 18, 2008Nationwide• Synaptic Corp

Spectranetics Corporation: Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, ti...

The catheter pouch label was incorrectly labeled with the wrong size.

FDAJul 4, 2008Nationwide• Spectranetics Corporation

Philips Healthcare Informatics, Inc.: Philips Healthcare Informatics iSite PACS (Picture Archi...

Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.

FDAJul 3, 2008Nationwide• Philips Healthcare Informatics, Inc.

Volk Optical Inc: G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens fo...

The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.'

FDAJun 30, 2008Nationwide• Volk Optical Inc

Roche Diagnostics Corp.: Roche/Hitachi Modular E Module immunoassay analyzer, Roch...

A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.

FDAJun 24, 2008Nationwide• Roche Diagnostics Corp.

Sybaritic, Inc: Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9...

Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.

FDAJun 18, 2008MI• Sybaritic, Inc