BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detecti
FDA device recall Z-0225-2009 · posted 2008-10-31 · Terminated
Recall details
- Recalling firm
- BD Diagnostics (GeneOhm Sciences, Inc)
- 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
- Action taken
- BD 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NQX
- Quantity affected
- 17 kits (200 test/kit) = 3400 test
- Distribution
- Nationwide to FL, NJ, NY, OH & PA and Internationally to Belgium
- Date initiated
- 2008-07-21
- Date posted
- 2008-10-31
- Date terminated
- 2010-03-04
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IDI-MRSA ASSAY (K042357) | Infectio Diagnostic (I.D.I.), Inc. | 2004-10-22 |