Reagents, Specific, Analyte

Herpes (HSV-1 & HSV-2) Test

Distribution without premarket approval/clearance.

Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in

The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.

In-vitro diagnostic kits:

Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

CD11b APC: ASR, REF: 340936, and CE, REF: 333143

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy.

Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent

An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.

Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: C

False positive reaction on the reagent.

Aquarius D13S319 Plus Deletion Probe, Model LPH068-A

There is an error in the chromomap on the package insert.