FDA Device Recalls

Class IIITerminated

Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place

Richard-Allan Scientific Company

Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.

February 16, 2016 · DeviceView details →

Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities

BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.

OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.

FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D

11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P

ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP

Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5

ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W

10-Panel Pipette Drug Screen, Item No. PSP-10M

iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013