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U.S. Department of Health and Human Services

Class 2 Device Recall BD GeneOhm MRSA Assay

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  Class 2 Device Recall BD GeneOhm MRSA Assay see related information
Date Initiated by Firm November 11, 2008
Date Posted September 10, 2009
Recall Status1 Terminated 3 on November 29, 2011
Recall Number Z-1963-2009
Recall Event ID 52107
510(K)Number K042357  
Product Classification System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - Product Code NQX
Product BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit).

For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.
Code Information Catalog Number: 441242, Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a; and  Catalog Number: 441244, Lot Number: 03T08218.
Recalling Firm/
Manufacturer		 BD Diagnostics (GeneOhm Sciences, Inc)
6146 Nancy Ridge Dr
San Diego CA 92121
For Additional Information Contact
858-334-6356
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
Action BD Diagnostics GeneOhm began contacting consignees by phone November 17, 2008 followed by a letter dated November 21, 2008 instructing discontinued use of the affected lots. Consignees were also asked to complete and return the enclosed Field Action Verification form. To arrange for product replacement or for further information, contact BD Diagnostics Technical Service at 1-888-436-3646 extension 2.
Quantity in Commerce 114 kits
Distribution Worldwide Distribution -- US (CA, IL, IN, KT, MD, ME, MN, MO, MT, NC, NJ, NY, OK, PA, TN, TX, UT, VA, and WI), Belgium and Japan.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NQX and Original Applicant = INFECTIO DIAGNOSTIC (I.D.I.) INC.
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