FDA Device recall Z-2138-2014
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests
- FDA Device
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests by Advandx, citing positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2138-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-04 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advandx |
| Distribution | AZ, FL, ID, MI, MO, NJ, OH, VA |
Product
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)
Reason
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Identifiers
| code_info | Lot Number: 04914 Exp. Date: 2015-06 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2138-2014%22
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