Recalls / —
—#106995
Product
SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media.
- FDA product code
- JWX — Kit, Screening, Staphylococcus Aureus
- Device class
- Class 1
- Medical specialty
- Microbiology
- 510(k) numbers
- K923212
- Affected lot / code info
- Catalog #73113, Lot number: 1105104545
Why it was recalled
Reports of false negative results in organism identification.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Biomerieux sent an "URGENT PRODUCT REMOVAL NOTICE" dated December 21, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer. The letter instructs the customer to stop using and to destroy the affected products. The firm recommends steps to follow when interpreting results. An acknowledgement and Product Replacement Form was enclosed for the customer to complete and return to the firm. Contact Biomerieux Customer Service representative at (800) 682-2666 for information regarding this notice.
Recalling firm
- Firm
- bioMerieux, Inc.
- Address
- 100 Rodolphe St, Durham, North Carolina 27712-9402
Distribution
- Distribution pattern
- Distributed to one customer in California.
Timeline
- Recall initiated
- 2011-12-21
- Posted by FDA
- 2012-02-16
- Terminated
- 2013-09-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #106995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.