FDAApril 26, 2019device
Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identificati...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is an error in the chromomap on the package insert.
What to do
FDA enforcement status: Terminated
Brands named
cytocell
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDARET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.2023-05-24
- FDARET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.2023-05-24
- FDACytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD397812022-10-27
- FDACytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD397822022-10-27
- FDACytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN0082022-02-14
- FDATCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A2022-02-04
- FDADel(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH0242022-01-18
- FDACytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)2021-05-27
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