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    EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code DNN·March 27, 2008

    EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

    FDA Recall
    Terminated ·Hospira, Inc.·Product code DNN·July 26, 2010

    740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008

    PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DHN·June 30, 2004

    C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DCN·April 25, 2019

    Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DCN·November 6, 2020

    ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code DHN·December 4, 2008

    Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DCN·February 19, 2019

    Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DCN·March 11, 2025

    Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.

    FDA Recall
    Terminated ·Inova Diagnostics Incorporated·Product code DHN·September 26, 2011

    Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code DHN·July 21, 2003

    Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product labeled "BIO-RAD Kallestad (TM) Mouse Stomach/Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette".

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code DHN·July 29, 2008

    Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DCN·April 15, 2008

    Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DHN·September 24, 2004

    "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code DHN·June 30, 2010

    Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020

    FDA Recall
    Terminated ·Den-Tal-Ez Inc, Star Dental Div·May 16, 2003

    Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TOTAL KNEE CDS-LF n. TOTAL SHOULDER CDS-LF o. TOTAL KNEE CDS-3 p. TOTAL HIP CDS-3 q. LOWER EXTREMITY CDS-LF r. TOTAL HIP-LF s. TOTAL HIP/KNEE CDS t. SPINE PROCEDURE u. OPEN HEART v. LAMI w. UPPER EXTREMITY CDS x. LOWER EXTREMITY CDS y. KNEE ARTHROSCOPY CDS z. KNEE ARTHROSCOPY CDS-LF aa. SHOULDER CDS-LF bb. PODIATRY CDS cc. KNEE ARTHROSCOPY CDS dd. SHOULDER ARTHROSCOPY CDS ee. ACL CDS ff. CRANIOTOMY CDS gg. TOTAL KNEE CDS hh. TOTAL KNEE ii. TOTAL HIP CDS jj. NEW LONDON TOTAL KNEE CDS kk. TRAUMA CDS-LF ll. TOTAL JOINT CDS mm. CRANIOTOMY CDS-1 nn. SHOULDER CDS-1 oo. SPINE CDS-1 pp. TOTAL KNEE CDS-1 qq. TOTAL HIP CDS-1 rr. LOWER EXTREMITY CDS-2 ss. HAND CDS-2 tt. KNEE ARTHROSCOPY CDS-2 uu. HAND CDS vv. BACK CDS ww. FRACTURE TABLE CDS xx. ORTHO OP CDS yy. ARTHROSCOPY CDS zz. ORTHO MINOR CDS aaa. TOTAL JOINT KNEE CDS bbb. TOTAL JOINT HIP CDS ccc. SHOULDER CDS-LF ddd. ZALE CRANIOTOMY CDS eee. ZALE TOTAL KNEE CDS fff. ZALE EXTREMITY CDS ggg. OPEN SHOULDER CDS hhh. LOWER EXTREMITY CDS iii. FHT TOTAL HIP jjj. FHT TOTAL KNEE RPLCMNT kkk. TOTAL HIP CDS lll. TOTAL KNEE CDS mmm. CCOC ACL-LF nnn. CCOC SPINAL FUSION ooo. CCOC MAJOR EXTREMITY ppp. EXTREMITY CDS qqq. PODIATRY CDS rrr. SHOULDER CDS sss. DISTAL LEG CDS ttt. HIP NAILING CDS uuu. SHOULDER CDS vvv. TOTAL HIP CDS www. UPPER EXTREMITY CDS xxx. BASIC ORTHO CDS yyy. TOTAL HIP PROCEDURE zzz. TOTAL JOINT CDS-LF aaaa. SHOULDER CDS-LF bbbb. HAND CDS-LF cccc. KNEE ARTHROSCOPY CDS-LF dddd. TOTAL JOINT eeee. UPPER EXTREMITY CDS ffff. LOWER EXTREMITY CDS gggg. GENERAL ORTHO CDS hhhh. ARTHROSCOPY CDS iiii. KNEE ARTHROSCOPY CDS jjjj. SHOULDER ARTHROSCOPY CDS kkkk. KNEE ARTHROSCOPY CDS llll. TOTAL ORTHO CDS mmmm. GROTH LOWER EXTREMITY CDS nnnn. HIP TOTAL PACK-ANTERIOR oooo. PRAIRIE STAR SPINE CDS pppp. 4TH FLOOR SHOULDER ARTHROSCOPY qqqq. FOOT & ANKLE CDS-LF rrrr. LAMI MICRODISC-LF ssss. HIP PINNING CDS-LF tttt. KNEE ARTHROSCOPY CDS-LF uuuu. UPPER EXTREMITY CDS-LF vvvv. SPINE CDS-LF wwww. SPINE CDS-LF xxxx. LOWER EXTREMITY/ELBOW CDS yyyy. HAND CDS zzzz. KNEE ARTHROSCOPY CDS aaaaa. SPINE CDS bbbbb. TOTAL HIP CDS ccccc. KNEE ARTHROSCOPY CDS ddddd. HAND CDS eeeee. TOTAL KNEE CDS-LF fffff. SPINE MODULE CDS ggggg. UPPER EXTREMITY CDS-LF hhhhh. TOTAL JOINT CDS iiiii. TOTAL JOINT CDS jjjjj. ORTHO TRAUMA CDS kkkkk. ACF CDS lllll. CRANIOTOMY CDS mmmmm. TOTAL JOINT CDS nnnnn. ARTHROSCOPY CDS ooooo. EXTREMITY CDS ppppp. PODIATRY CDS qqqqq. LAMINECTOMY CDS rrrrr. EXTREMITY CDS sssss. TOTAL KNEE CDS ttttt. TOTAL HIP CDS uuuuu. TOTAL KNEE vvvvv. ANTERIOR HIP wwwww. HAND WRIST FOREARM xxxxx. LOWER EXTREMITY yyyyy. TOTAL HIP zzzzz. TOTAL KNEE aaaaaa. SHOULDER ARTHROSCOPY bbbbbb. SHOULDER ARTHROSCOPY PK cccccc. LUMBAR LAMINECTOMY PACK dddddd. CRANIOTOMY PACK-LF eeeeee. OPEN SHOULDER PACK-LF ffffff. TOTAL HIP PACK-LF gggggg. TOTAL KNEE PACK-LF hhhhhh. SHOULDER ARTHROSCOPY PACK-LF iiiiii. EXTREMITY PACK jjjjjj. CLOSED HEART PEDS PACK kkkkkk. ORTHO MINOR PACK-LF llllll. FRACTURE TABLE PACK-LF mmmmmm. HAND - EDOC PACK-LF nnnnnn. FOOT LV - EDOC PACK-LF oooooo. SHOULDER - EDOC PACK-LF pppppp. FOOT ANKLE PACK-LF qqqqqq. OPEN HEART TRAY rrrrrr. SHOULDER PACK-LF ssssss. ROCKVILLE ASC EXTREMITY PACK tttttt. NEURO SPINE DRH PACK-LF uuuuuu. DRH ORTHOPEDIC I AND D PACK-LF vvvvvv. KNEE ARTHROSCOPY MIOSH PACK-LF wwwwww. HAND AND FOOT PACK-LF xxxxxx. SPINE BUNDLE PACK yyyyyy. MINOR ORTHOPEDIC PACK-LF zzzzzz. FEM POP PACK-LF aaaaaaa. LAMINECTOMY PACK-LF bbbbbbb. CRANIOTOMY PACK-LF ccccccc. MAJOR ORTHO PACK-LF ddddddd. HAND WRIST PACK-LF eeeeeee. TOSH PODIATRY PACK-LF fffffff. TOTAL HIP ARTHROPLASTY PACK-LF ggggggg. TOSH UPPER EXTREM MIOSH PK-LF hhhhhhh. OPEN HEART CHILDRENS PACK-LF iiiiiii. CRANIOTOMY PACK-LF jjjjjjj. SPINE HARPER PACK-LF kkkkkkk. CRANIOTOMY

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·November 17, 2022

    ORAcollect RNA: ORE-100

    FDA Recall
    Open, Classified ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code QJR·February 18, 2022

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    FDA Recall
    Terminated ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020

    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025

    FDA Recall
    Open, Classified ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code OYJ·February 18, 2022