AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
FDA Recall Z-2138-2014 · Posted 2014-08-01
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Recalling FirmAdvandx Inc
Recall StatusTerminated
Product CodeNXX
Date Initiated2014-07-04
Date Terminated2014-09-30
Product Quantity10 kits
Reason for Recall
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Firm Action
AdvanDx notified customers by e-mail on July 4, 2014 of the problem and advised to discontinue use of the QuickFISH Fixation Kits with Lot#04914. Replacement kits were immediately shipped to all of the affected customers. Questions contact local AdvanDx representative or Technical Support 1-866-376-0009, fax 1-781-376-0111 or e-mail: [email protected].
An acknowledgement of Receipt and Destruction of Materials requested to be completed.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
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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