Recall Z-1898-2010 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cepheid
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturin
| Date | Jul 1, 2010 (initiated Apr 5, 2010) |
| Status | Terminated |
| Reason | The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Cepheid, issued a technical bulletin to customers on April 5, 2010 and an updated to the April 5 bulletin dated April 9, 2010 instructing them to perform a reflexive repeat test on any blood culture results initially determined as having SA. If further information on this please contact your Cepheid Sales Representative 1-888-336-2743 or www.CEPHEID.COM. |
| Quantity | 5,510 units |
| Distribution | Worldwide distribution: USA and Europe, Taiwan, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082140 | XPERT MRSA/SA BLOOD CULTURE ASSAY Cepheid, Sep 29, 2008 |