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U.S. Department of Health and Human Services

Class 2 Device Recall BD GeneOhm MRSA

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 Class 2 Device Recall BD GeneOhm MRSAsee related information
Date Initiated by FirmJuly 21, 2008
Date PostedOctober 31, 2008
Recall Status1 Terminated 3 on March 04, 2010
Recall NumberZ-0225-2009
Recall Event ID 49470
510(K)NumberK042357 
Product Classification Assay - Product Code NQX
ProductBD 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.
Code Information Lot 03T08102
Recalling Firm/
Manufacturer
BD Diagnostics (GeneOhm Sciences, Inc)
6146 Nancy Ridge Dr
San Diego CA 92121
For Additional Information ContactRaymond J. Boul¿
858-334-6356
Manufacturer 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 2
Nonconforming Material/Component
ActionBD 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.
Quantity in Commerce17 kits (200 test/kit) = 3400 test
DistributionNationwide to FL, NJ, NY, OH & PA and Internationally to Belgium
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NQX
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