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TruSight™ Cystic Fibrosis Library Preparation
ILLUMINA, INC. · Model 20036925 · UDI-DI 00816270020149
PFT
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
13
Facilities
Description
The TruSight™ Cystic Fibrosis Library Prep is a library preparation kit that supports the TruSight Cystic Fibrosis 139 Variant Assay and the TruSight Cystic Fibrosis Clinical Sequencing Assay. The TruSight Cystic Fibrosis Library Preparation is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035693, TruSight™ Cystic Fibrosis Library Prep, 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep, 3/3.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-28 | Illumina, Inc. | An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality i |
| 2018-04-26 | Horiba Instruments, Inc dba Horiba Medical | When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of |
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