Antibody Igm,if, Cytomegalovirus Virus
Microbiology · 21 CFR 866.3175
Recent MDR events
156 adverse event reports on file
- VIDAS® CMV IGMJul 12, 2022MalfunctionBiomérieux Sa8020790-2022-00078
- VIDAS® CMV IGMMay 5, 2022MalfunctionBiomerieux Sa8020790-2022-00054
- VIDAS® CMV IGMApr 27, 2022MalfunctionBiomérieux Sa8020790-2022-00053
- VIDAS® CMV IGMApr 13, 2022MalfunctionBiomerieux Sa8020790-2022-00046
- VIDAS® CMV IGMMar 11, 2022MalfunctionBiomérieux Sa8020790-2022-00039
- VIDAS® CMV IGMMar 4, 2022MalfunctionBiomérieux Sa8020790-2022-00037
- VIDAS® CMV IGMFeb 17, 2022MalfunctionBiomérieux Sa8020790-2022-00033
- VIDAS® CMV IGMFeb 10, 2022MalfunctionBiomérieux Sa8020790-2022-00026
- VIDAS® CMV IGMFeb 10, 2022MalfunctionBiomérieux Sa8020790-2022-00027
- VIDAS® CMV IGMFeb 10, 2022MalfunctionBiomérieux Sa8020790-2022-00028
Event type breakdown
Recalls
8 recall events for this product code
- bioMerieux, Inc.TerminatedMar 14, 2022
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Invalid calibrations (out of range high) while using the product.
Z-0742-2022 · View FDA record ↗ - QIAGEN Gaithersburg, Inc.TerminatedMay 14, 2013
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225)
CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Z-1320-2013 · View FDA record ↗ - QIAGEN Gaithersburg, Inc.TerminatedMay 14, 2013
QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223)
CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Z-1321-2013 · View FDA record ↗ - Quest International, Inc.TerminatedJan 23, 2012
SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells
Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.
Z-0837-2012 · View FDA record ↗ - Abbott LaboratoriesTerminatedJul 11, 2007
AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.
Z-1035-2007 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Iden
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
Z-0319-2017 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Ca
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
Z-0320-2017 · View FDA record ↗ - Biomerieux IncTerminatedUnknown
VIDAS CMV IgM 30 Tests
bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01).
Z-1408-2021 · View FDA record ↗
Registered firms
10 firms currently registered for this product code
Biomerieux Sa
MARCY L ETOILE Rhone, FR
Zeus Scientific Llc
BRANCHBURG, NJ, US
Acro Biotech Inc.
Montclair, CA, US
Lgc Clinical Diagnostics, Inc.
Milford, MA, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Bio-rad Laboratories, Inc.
Hercules, CA, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
510(k) clearances
18 clearances for this product code
- Siemens Healthcare DiagnosticsMay 13, 2010
K100433 · IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
- Boston Biomedica, Inc.Aug 22, 1997
K972884 · ACCURUN 146 CMV IGM POSITIVE CONTROL
- Biomerieux Vitek, Inc.Aug 2, 1994
K933549 · VIDAS CMV IGM ASSAY
- Baxter Diagnostics, Inc.Apr 8, 1993
K922580 · BARTELS CYTOMEGALOVIRUS IGM EIA
- Sclavo, Inc.Mar 4, 1992
K914789 · ELISA CMV IGM
- Pb Diagnostics, Inc.Oct 28, 1991
K913080 · OPUS(R) ANTI CMV-M
- Zeus Scientific, Inc.Apr 26, 1990
K900743 · CMV-IGM IFA TEST SYSTEM
- Immuno Concepts, Inc.Jul 25, 1989
K893465 · CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)