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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 461–480 of 786 recalls

Class IIITerminated

DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · Device

View details →

Class IIITerminated

ProScreen 12 Panel Dip Card, Item No. PSD-12BUP

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

DrugSmart 9 Test Cup (BUP), Item No. 60960D

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

EDI BZO Uncut Sheet - Cup*, Item No. 160170

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU

Ameditech Inc

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

November 16, 2015 · DeviceView details →

Class IIITerminated

MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

Diagnostic Hybrids, Inc.

A component of the kit was found to contain bacterial contamination.

November 3, 2015 · DeviceView details →

Class IIITerminated

MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

Diagnostic Hybrids, Inc.

A component of the kit was found to contain bacterial contamination.

November 3, 2015 · DeviceView details →

Class IIITerminated

MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

Diagnostic Hybrids, Inc.

A component of the kit was found to contain bacterial contamination.

November 3, 2015 · DeviceView details →

Class IIITerminated

DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

BC Group International Inc

Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

October 28, 2015 · DeviceView details →

Class IIITerminated

Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.

Lab Vision Corporation

It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml.

October 27, 2015 · DeviceView details →

Class IIITerminated

Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

C.R. Bard, Inc.

Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.

October 2, 2015 · DeviceView details →

Class IIITerminated

BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.

Becton, Dickinson and Company, BD Biosciences

Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.

September 30, 2015 · DeviceView details →

Class IIITerminated

VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.

Ortho-Clinical Diagnostics

The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.

September 28, 2015 · DeviceView details →

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