BIO-RAD LABORATORIES INC

Substantially Equivalent

Substantially Equivalent

Substantially Equivalent

Substantially Equivalent

Substantially Equivalent

Substantially Equivalent

Substantially Equivalent

Substantially Equivalent

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%).…

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%).…

Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause …

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause …

A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.

Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet. Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit.

EBV IgM Control Set

Manual & CDs, EBV IgM IFU, SW4.1_v1

BioPlex 2200 Operation Manual version 4.3 Multiple Language CD-ROM

U.S. Only IFU, Manual & CDs, MMRV IgG IFU, SW4.1_v1

U.S. IFU, Manual & CDs, BioPlex 2200 Syphilis Total & RPR SW4.3

ToRC IgG Control Lot Data

Manual & CDs, Celiac IgA and IgG IFU, SW4_v1

25-OH Vitamin D Reagent Pack

ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2

Syphilis IgG Calibrator Set

BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5

ANA Screen Control Lot Data

APLS IgG Calibrator Set

ANA Screen Control Set

BioPlex 2200 Lyme Total Control Set

EBV IgM Calibrator Lot Data

Rubella & CMV Control Set

EBV IgG Calibrator Set

BioPlex 2200 Syphilis Total & RPR Control Set

BioPlex 2200 25-OH Vitamin D Control Lot Data

APLS IgG Calibrator Lot Data

Celiac IgA Calibrator Set

APLS IgA Calibrator Lot Data

HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2

BioPlex 2200 ToRC IgM Calibrator Lot Data

Manual & CDs, ANA Screen with MDSS IFU, SW 4_v2

Celiac IgA Reagent Pack

25-OH Vitamin D Control Set

Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only

HSV-1 & HSV-2 IgG Calibrator Lot Data

EBV IgM Control Lot Data

BioPlex 2200 25-OH Vitamin D Control Set

Vasculitis Calibrator Set

Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1

APLS IgA Reagent Pack

BioPlex 2200 Syphilis Total & RPR Calibrator Lot Data

Rubella & CMV IgM Calibrator Set

BioPlex 2200 Syphilis Total & RPR Calibrator Set

Manual & CDs, BioPlex 2200, Syphilis IgG IFU, SW4_v2

Celiac IgG Calibrator Lot Data

BioPlex 2200 Lyme Total Calibrator Set

Anti-CCP Control Set

BioPlex 2200 Lyme Total Control CD

Vasculitis Control Set

EBV IgG Reagent Pack

APLS IgM Control Lot Data

Anti-CCP Assay Protocol File CD, SW4_v3

ToRC IgG Control Set

Manual & CDs, Syphilis IgG IFU, SW4.1_v1

ANA Screen with MDSS Reagent pack

EBV IgG Calibrator Lot Data

Manual & CDs, 25-OH Vitamin D IFU, SW4.2_v3 US Only

BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5

BioPlex 2200 ToRC IgM Control Set

ANA Screen with MDSS Reagent Pack

BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1

EBV IgM Calibrator Set

BPX2200, Analyzer System, Refurbishment

Celiac IgG Reagent Pack

Syphilis IgG Calibrator Lot Data

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