BEUDAMED
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    Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code JOJ·February 25, 2003

    Cidexplus Solution Test Strips

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code JOJ·March 16, 2005

    Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products''

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code JOJ·September 4, 2003

    VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270F using typical healthcare dynamic air removal steam sterilization cycles.

    FDA Recall
    Terminated ·Steris Corporation·Product code JOJ·December 19, 2013

    Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code JOJ·September 4, 2003

    Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code JOJ·August 10, 2022

    Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101

    FDA Recall
    Terminated ·Propper Mfg Co Inc·Product code JOJ·February 7, 2008

    Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome

    FDA Recall
    Terminated ·Steritec Products Mfc. Co., Inc.·Product code JOJ·June 10, 2013

    Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code JOJ·September 4, 2003

    3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

    FDA Recall
    Terminated ·Product code JOJ·August 9, 2006

    Cidex Plus Test Strips

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code JOJ·December 17, 2003

    regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.

    FDA Recall
    Terminated ·Resource Optimization & Innovation LLC·Product code JOJ·June 17, 2020

    3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical indicator ink that turns from red to green when exposed to ethylene oxide (EO) sterilization process. It is designed to indicate whether EO has penetrated to the point of placement of the strip, usually the center of the pack. Each strip is perforated at the center if a shorter internal chemical indicator is preferred. An internal chemical indicator should be used inside each pack to be sterilized. 3M Health Care 3M Center Bldg 275-4E-011, St. Paul, MN 55144-1000

    FDA Recall
    Terminated ·Product code JOJ·March 19, 2008

    Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.

    FDA Recall
    Terminated ·Steritec Products Mfc. Co., Inc.·Product code JOJ·July 15, 2009

    Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Challenge Packs are used to confirm that that critical parameters of steam sterilization have been reached within a challenging test pack design. Each challenge pack is also specific to a sterilization temperature and type (i.e. 275F 3 minute Prevacuum Cycle).

    FDA Recall
    Terminated ·Steris Corporation·Product code JOJ·March 16, 2011

    Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.

    FDA Recall
    Terminated ·Steritec Products Mfc. Co., Inc.·Product code JOJ·June 10, 2013

    Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.

    FDA Recall
    Terminated ·Steritec Products Mfc. Co., Inc.·Product code JOJ·July 15, 2009

    Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250F 30 minute Gravity Cycle).

    FDA Recall
    Terminated ·Steris Corporation·Product code JOJ·March 16, 2011

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Recall
    Terminated ·Euro Diagnostica AB·Product code LKJ·October 15, 2015

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·March 14, 2018