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    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code MKJ·July 26, 2012

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code MKJ·July 26, 2012

    biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code MKT·June 13, 2007

    ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTO·April 12, 0013

    BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled in part ***Methylene Blue Loeffler***Becton Dickinson and Company***Packaged in Mexico*** Lactophenol cotton blue is a blue stain used for direct examination of clinical specimens for fungal elements.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JTO·September 28, 2009

    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

    FDA Recall
    Terminated ·Remel Inc·Product code JTO·May 2, 2013

    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    API JAMES 2AMP, CATALOG 70542

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.

    FDA Recall
    Terminated ·Remel Inc·Product code JTO·May 2, 2013

    API NIT1 NIT2 REAGENTS, CATALOG 70442

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    API VP1 VP2 REAGENTS, CATALOG 70422

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338

    FDA Recall
    Terminated ·Hardy Media Inc Dba Hardy Diag·Product code JTO·December 31, 2003

    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.

    FDA Recall
    Terminated ·Gibson Bioscience·Product code JTO·July 1, 2021

    BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022