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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

475

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 441–460 of 475 recalls

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

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 Healthcare Diagnostics, Inc.: Siemens Stratus CS Acute Care Troponin I CalPak. In vitr...

The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that

FDAApr 28, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

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Siemens Healthcare Diagnostics, Inc.: Dimension Flex Reagent Cartridge C-Reactive Protein Exten...

falsely elevated results in EDTA plasma samples

FDAApr 15, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Cardiac Troponin I Flex reagent cartridge (CTN...

possibility of falsely elevated results

FDAApr 8, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics Inc.: Dimension Total Prostate Specific Antigen (TPSA) Flex Rea...

False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.

FDAMar 24, 2008Nationwide• Siemens Healthcare Diagnostics Inc.

Medtox Diagnostics Inc: MEDTOXscan Reader

Reader was marketed without a 510(k).

FDAFeb 8, 2008Nationwide• Medtox Diagnostics Inc

Diagnostica Stago, Inc.: STA Compact and STA Compact CT, Haemostasis Analyzer, in ...

Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

FDAJul 30, 2007Nationwide• Diagnostica Stago, Inc.

Focus Diagnostics Inc: HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended...

A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.

FDAJul 6, 2007CA, CT, IL +2 more• Focus Diagnostics Inc

Humagen Fertility Diagnostics, Inc.: IVF Pasteur Pipettes, glass, cotton plugged, length 9", ...

Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

FDAMay 8, 2007IL, IN• Humagen Fertility Diagnostics, Inc.

Diagnostica Stago, Inc.: STA Liatest Free Protein S For in vitro diagnostic use. 2...

Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.

FDAMay 8, 2007Nationwide• Diagnostica Stago, Inc.

Meretek Diagnostics, Inc.: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1....

Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

FDAMay 2, 2007Nationwide• Meretek Diagnostics, Inc.

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.

FDAMar 30, 2007Nationwide• Diagnostica Stago, Inc.

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.

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.

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.

Diagnostica Stago, Inc.: Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal P...

Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

FDAJul 18, 2006Nationwide• Diagnostica Stago, Inc.

Louisville Apl Diagnostics Inc: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in v...

Product mislabeled; outer container labeled with incorrect lot number.

FDAJul 18, 2006IN• Louisville Apl Diagnostics Inc

ABX Diagnostics Inc: ABX Pentra 120,120R,120DX, automated hematology analyzer

Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.

FDAMar 24, 2006Nationwide• ABX Diagnostics Inc

Chembio Diagnostic System Inc: Sickle-STAT Test Kit, Catalog # SC901, a qualitative test...

Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.

FDADec 16, 2005Nationwide• Chembio Diagnostic System Inc