BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0225-2009 · Initiated July 21, 2008

    Recall

    Recall Number
    Z-0225-2009
    Event Number
    49470
    Firm
    BD Diagnostics (GeneOhm Sciences, Inc)
    FEI Number
    3004788834
    Product Code
    NQX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 21, 2008
    Posted
    October 31, 2008
    Terminated
    March 4, 2010
    Address
    6146 Nancy Ridge Dr, San Diego, CA, 92121

    Description

    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.

    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

    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 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.

    Distribution

    Nationwide to FL, NJ, NY, OH & PA and Internationally to Belgium

    Quantity

    17 kits (200 test/kit) = 3400 test