Recall Z-0226-2009 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
BD Diagnostics (GeneOhm Sciences, Inc)
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, util
| Date | Oct 31, 2008 (initiated Jul 21, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | BD Diagnostics GeneOhm (BDDG) initial recall notification was made on 07/21/2008 by telephone and followed up with written notification on 07/22/2008. Domestic customers were advised to check their stock to determine if they have inventory remaining of the recalled lot. If so, BD GeneOhm Technical Service will arrange for return of unused product from the customer. The were provided with a Recall Verification form to complete and return. The customers were instructed if they have remaining tests from the affected referenced lot, please discontinue use immediately. They were also told th |
| Quantity | 60 kits (48 test/kit) =2880 test |
| Distribution | Nationwide to FL, NJ, NY, OH & PA and Internationally to Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042357 | IDI-MRSA ASSAY Infectio Diagnostic (I.D.I.), Inc., Oct 22, 2004 |