Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. M
FDA device recall Z-1898-2010 · posted 2010-07-01 · Terminated
Recall details
- Recalling firm
- Cepheid
- Reason for recall
- The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NQX
- Quantity affected
- 5,510 units
- Distribution
- Worldwide distribution: USA and Europe, Taiwan, and Australia.
- Date initiated
- 2010-04-05
- Date posted
- 2010-07-01
- Date terminated
- 2011-05-25
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XPERT MRSA/SA BLOOD CULTURE ASSAY (K082140) | Cepheid | 2008-09-29 |