BD Diagnostics (Geneohm Sciences, Inc.)
San Diego, CA, US
Bd Diagnostics (Geneohm Sciences, Inc.) appears in FDA device records in San Diego, CA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for BD Diagnostics (Geneohm Sciences, Inc.) between 2008 and 2009. The busiest year on record is 2008, with 1. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1963-2009 | BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen. | 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. | Terminated | ||
| Z-0226-2009 | BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing. | 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 | Terminated | ||
| Z-0225-2009 | BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing. | 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 | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain