RegWardenFDA facility compliance records
Facility

BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH

16 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2015: 2 recalls; 2018: 2 recalls; 2019: 2 recalls; 2020: 1 recalls; 2021: 1 recalls; 2022: 3 recalls; 2023: 2 recalls; 2024: 1 recalls1’121’13’142’15’16’172’182’191’201’213’222’231’24’25’26
  • Recalls (16)

Devices registered here (1)

  • System, Test, Automated Blood Grouping And Antibody
    Product code KSZ (opens in a new tab) · Class II · Hematology · 21 CFR 864.9175

Recalls & enforcement

20241 record
  • Class IIOngoing2024-02-15
    Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
20232 records
  • Class IIOngoing2023-02-28
    APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
  • Class IIOngoing2023-02-21
    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 ex…
20223 records
  • Class IIOngoing2022-10-19
    Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
  • Class IIOngoing2022-04-14
    Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
  • Class IIOngoing2022-02-08
    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
20211 record
  • Class IIOngoing2021-09-17
    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,…
20201 record
  • Class IIOngoing2020-04-21
    The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
20192 records
  • Class IITerminated2019-11-01
    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.
  • Class IIOngoing2019-01-10
    User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).
20182 records
  • Class IITerminated2018-06-08
    Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
  • Class IITerminated2018-04-02
    The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.
20152 records
  • Class IITerminated2015-12-22
    The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.
  • Class IIITerminated2015-05-13
    The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
20131 record
  • Class IIITerminated2013-08-20
    The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.
20121 record
  • Class IITerminated2012-07-27
    Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH (FEI 3016014873) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016014873-bio-rad-medical-laboratories-logistik-gm/

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