BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.
FDA Recall Z-2316-2012 · Posted 2012-09-06
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeLLH
Date Initiated2012-05-22
Date Terminated2012-11-02
Product Quantity38 kits
Reason for Recall
Leakage in Cepheid SmartCycler reaction tubes.
Firm Action
BD Diagnostic Systems issued an Urgent Product Recall letter via UPS overnight delivery on May 22, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions:
Discontinue use and discard any affected product. BD would send replacement tubes for the discarded material.
Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification.
Fax the form to:
Attention: Regulatory Compliance
FAX: 410-316-4258
Email: [email protected]
If further assistance is needed, customers should contact BD Technical Services Department at 1-800-838-8663.
For questions regarding this recall call 410-316-4054.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.