Data / Medical devices / United States / Diasorin Inc.
Diasorin Inc.: FDA-registered device maker in Stillwater, MN, United States, 27 510(k) clearances
Diasorin Inc. is registered with the FDA (registration 2182595) in Stillwater, MN, United States. It lists 46 device types. The FDA files 27 510(k) clearances under its listings, the newest dated July 26, 2022. 39 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2182595
- Address
- 1951 Northwestern Ave, Stillwater, MN, United States, 55082
- Owner or operator
- DiaSorin Inc. (9051149)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- April 29, 1991
- Registered through
- 2027
- Brand names listed
- AldoCTK - RIA, COMPLEMENT ACTIVATION EIA (CAE) KIT, LIAISON 1-84, LIAISON 1-84 PTH Assay, LIAISON 1-84 PTH Cal Verifiers, LIAISON 1-84 PTH Control Set, LIAISON 1-84 PTH Specimen Diluent, LIAISON 25 OH Vitamin D TOTAL Assay and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2022 | K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | NXO | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| July 14, 2022 | K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | QPS | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| February 18, 2021 | K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | LSR | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| February 18, 2021 | K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | LSR | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| May 6, 2020 | K192586 | LIAISON® Folate | CGN | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| March 2, 2020 | K193532 | LIAISON Anti-HAV Assay | LOL | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| January 29, 2020 | K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | LSR | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| October 28, 2019 | K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | QFO | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| October 2, 2019 | K192064 | LIAISON Vitamin B12 | CDD | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| December 26, 2018 | K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device | NXO | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| August 31, 2018 | K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | LYR | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| July 22, 2016 | K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | LYR | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| June 30, 2016 | K161522 | LIAISON EBV IgM Serum Control Set | JJX | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| June 22, 2015 | K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers | CEW | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| December 10, 2014 | K141463 | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS | MRG | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| November 8, 2013 | K132515 | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS | CEW | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| April 9, 2013 | K130321 | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS | CJM | Substantially Equivalent | Diasorin | accessdata.fda.gov |
| January 25, 2013 | K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET | CDZ | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| January 20, 2012 | K112725 | LIAISON 25 OH VITAMIN D TOTAL ASSAY | MRG | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| September 9, 2009 | K090104 | LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 | JJX | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| November 18, 2008 | K081685 | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG | MXJ | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| November 10, 2008 | K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | MYF | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| October 1, 2007 | K071480 | LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 | MRG | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| April 12, 2007 | K062473 | LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 | LSR | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| July 31, 2006 | K061247 | DIASORIN LIAISON TREPONEMA ASSAY | LIP | Substantially Equivalent | DiaSorin, Inc. | accessdata.fda.gov |
| October 13, 1995 | K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | DAE | Substantially Equivalent | Incstar Corp. | accessdata.fda.gov |
| April 5, 1977 | K770057 | NDNA IMMUNOPATH FLUORO-KIT | DHN | Substantially Equivalent | Clinical Sciences, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 7, 2024 | 95829 | Class II | Ongoing | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens | Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an inc | accessdata.fda.gov |
| December 13, 2023 | 93741 | Class II | Ongoing | DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 | DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results. | accessdata.fda.gov |
| November 23, 2020 | 87501 | Class II | Terminated | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathy | Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. | accessdata.fda.gov |
| July 17, 2020 | 86152 | Class II | Ongoing | Parvovirus B19 IgG EIA kit Part No. V519IGUS | Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value | accessdata.fda.gov |
| July 13, 2016 | 75478 | Class II | Terminated | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results shou | DiaSorin is issuing an urgent medical device correction for the LIAISON Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON Estradiol II Gena assay should not be used to test patients being treated with fulvestrant (Faslodex). | accessdata.fda.gov |
| March 16, 2015 | 70773 | Class II | Terminated | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, F | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. | accessdata.fda.gov |
| August 19, 2010 | 57937 | Not yet classified | Terminated | ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended f | Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits, catalog number P001931, lot numbers 0650270A and/or 0650270A/1) may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. Internal testing has confirmed that when defined assay validation crit | accessdata.fda.gov |
| December 16, 2009 | 54124 | Not yet classified | Terminated | DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28. | DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed patient test results. | accessdata.fda.gov |
| October 12, 2009 | 53698 | Not yet classified | Terminated | GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA | The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range. | accessdata.fda.gov |
| December 5, 2008 | 50704 | Not yet classified | Terminated | Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use. | DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer. | accessdata.fda.gov |
| February 1, 2008 | 46832 | Not yet classified | Terminated | LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082 | Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high. | accessdata.fda.gov |
| August 21, 2007 | 39413 | Not yet classified | Terminated | 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. | 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer. | accessdata.fda.gov |
| March 14, 2007 | 37691 | Not yet classified | Terminated | DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern | A lot to lot inconsistency was noted on kits of ETI EBNA G. | accessdata.fda.gov |
| February 15, 2007 | 37606 | Not yet classified | Terminated | DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples) | Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay) | accessdata.fda.gov |
| June 5, 2006 | 37632 | Not yet classified | Terminated | 1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA | Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid) | accessdata.fda.gov |
| August 8, 2005 | 33128 | Not yet classified | Terminated | The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1). | Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG. | accessdata.fda.gov |
| April 8, 2005 | 31735 | Not yet classified | Terminated | DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy | The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926). | accessdata.fda.gov |
| March 16, 2005 | 31710 | Not yet classified | Terminated | Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississa | Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter. | accessdata.fda.gov |
| February 14, 2005 | 31228 | Not yet classified | Terminated | Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 | An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A curve can not be calculated from this data. | accessdata.fda.gov |
| February 14, 2005 | 31167 | Not yet classified | Terminated | LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E. | Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values. | accessdata.fda.gov |
| January 18, 2005 | 31095 | Not yet classified | Terminated | DiaSorin Analyte Specific Reagent | Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6. | accessdata.fda.gov |
| January 10, 2005 | 31104 | Not yet classified | Terminated | Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, L | QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification. | accessdata.fda.gov |
| November 1, 2004 | 30953 | Not yet classified | Terminated | DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C | The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit. | accessdata.fda.gov |
| November 1, 2004 | 30950 | Not yet classified | Terminated | DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom. | DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL). | accessdata.fda.gov |
| October 26, 2004 | 30924 | Not yet classified | Terminated | Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. | Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml. | accessdata.fda.gov |
| October 20, 2004 | 30930 | Not yet classified | Terminated | ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagn | 2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading of the positive control and calibrators, P10 and P50. The decline in OD of the positive control and calibrators (P10 & P50) would cause the assay validation criteria to fail. | accessdata.fda.gov |
| September 24, 2004 | 30946 | Not yet classified | Terminated | Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test. | A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. The graph may appear valid; however erroneous re | accessdata.fda.gov |
| July 15, 2004 | 30937 | Not yet classified | Terminated | DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative determination of androstenedione levels in serum. | Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution. | accessdata.fda.gov |
| June 30, 2004 | 30936 | Not yet classified | Terminated | DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A., Lot # 11330 | An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18. | accessdata.fda.gov |
| June 30, 2004 | 30934 | Not yet classified | Terminated | 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 a | The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160. | accessdata.fda.gov |
| May 25, 2004 | 30932 | Not yet classified | Terminated | DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. | Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used. | accessdata.fda.gov |
| May 20, 2004 | 30931 | Not yet classified | Terminated | Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays. | When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added. | accessdata.fda.gov |
| April 20, 2004 | 30920 | Not yet classified | Terminated | Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay. | An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing. | accessdata.fda.gov |
| April 12, 2004 | 30929 | Not yet classified | Terminated | Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit | The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert. | accessdata.fda.gov |
| April 12, 2004 | 30928 | Not yet classified | Terminated | Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). | The data reduction program written for a specific automated microtiter plate reader (Bio-Tek ELx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0. | accessdata.fda.gov |
| April 12, 2004 | 30922 | Not yet classified | Terminated | Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit | The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed. | accessdata.fda.gov |
| March 9, 2004 | 32608 | Not yet classified | Terminated | ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. | An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay. | accessdata.fda.gov |
| January 23, 2004 | 30919 | Not yet classified | Terminated | DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, | DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits. | accessdata.fda.gov |
| September 10, 2003 | 30891 | Not yet classified | Terminated | Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285 | Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results. | accessdata.fda.gov |
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Updated December 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.