BD Diagnostics (Geneohm Sciences, Inc.)
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Bd Geneohm Cdiff Assay Ref K081920
Regimes: 510(k) Registry: 510(k)Bd Max Mrsa Assay, Bd Max Instrument Ref K120138
Regimes: 510(k) Registry: 510(k)Bd Geneohm Staphsr Assay Ref K071026
Regimes: 510(k) Registry: 510(k)Bd Geneohm Mrsa Acp Assay Ref K093346
Regimes: 510(k) Registry: 510(k)
FDA recalls
2008
- 11 Nov 2008 Z-1963-2009 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 21 Jul 2008 Z-0225-2009 Unclassified (pre-2012) Terminated 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
- 21 Jul 2008 Z-0226-2009 Unclassified (pre-2012) Terminated 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
- 11 Nov 2008 Z-1963-2009 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Bd Diagnostics (Geneohm Sciences, Inc.) have in the registry?
The registry currently lists 4 devices for Bd Diagnostics (Geneohm Sciences, Inc.). Devices recorded under merged duplicate company entries are counted once.
Which registries list Bd Diagnostics (Geneohm Sciences, Inc.)'s devices?
Among its 4 most recently registered devices, Bd Diagnostics (Geneohm Sciences, Inc.) has devices listed in FDA 510(k) (4 devices).
What risk classes do Bd Diagnostics (Geneohm Sciences, Inc.)'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Bd Diagnostics (Geneohm Sciences, Inc.)'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bd Diagnostics (Geneohm Sciences, Inc.)?
FDA recall records list 3 recalls initiated by Bd Diagnostics (Geneohm Sciences, Inc.), the most recent initiated on 11 Nov 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bd Diagnostics (Geneohm Sciences, Inc.) in the registry?
The most recently registered devices listed for Bd Diagnostics (Geneohm Sciences, Inc.) include BD GENEOHM CDIFF ASSAY, BD MAX MRSA ASSAY, BD MAX INSTRUMENT, BD GENEOHM STAPHSR ASSAY and BD GENEOHM MRSA ACP ASSAY.