Recall Z-0226-2009
BD Diagnostics (GeneOhm Sciences, Inc) · initiated July 21, 2008
Product
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.
Codes / lots: Lot 03T08099 and 03T08099a
Reason for recall
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
FDA-determined cause: Nonconforming Material/Component
Action taken
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 that BD GeneOhm recommend that they review the results of samples tested using this lot of product. Look for any trends outside of the normal expected results, including any changes in MRSA positivity rates compared to your normal prevalence. If they have any questions or concerns following the review, please contact BDDG Technical Service to arrange for consultation with our Medical Director. An telephone number 1-858-334-6356 was given for customers to contact BDDG Technical Service.
Details
- Recall number
- Z-0226-2009
- Initiated
- July 21, 2008
- Posted by FDA
- October 31, 2008
- Terminated
- March 4, 2010
- Product code
- NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Quantity
- 60 kits (48 test/kit) =2880 test
- Distribution
- Nationwide to FL, NJ, NY, OH & PA and Internationally to Belgium
- Recalling firm
- BD Diagnostics (GeneOhm Sciences, Inc), San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0225-2009 | BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro…BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential… | 07/21/2008Terminated |