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 Recall Z-1045-2012 · Posted 2012-02-16
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Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeJWX
Date Initiated2011-12-21
Date Terminated2013-09-17
Product Quantity100 kits
Reason for Recall
Reports of false negative results in organism identification.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed to one customer in California.
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.
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