Advandx Inc: Medical Device Recall in 2014 - (Recall #: Z-2138-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: July 4, 2014

Date Posted: August 13, 2014

Recall Number: Z-2138-2014

Event ID: 68774

Reason for Recall:

Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

Status: Terminated

Product Quantity: 10 kits

Code Information:

Lot Number: 04914 Exp. Date: 2015-06

Distribution Pattern:

Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated