The Recall Desk

Manufacturer

CSL Behring GmbH

5 recalls in our database name CSL Behring GmbH as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2020-04-29

Of the 5 recalls from CSL Behring GmbH we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • ModerateFDA (Devices)·Z-1790-2020·2020-04-29

    CSL Behring Recalls Siemens N Latex CDT Kit for Negative Bias

    CSL Behring GmbH is recalling Siemens N Latex CDT Kits due to negative bias in carbohydrate-deficient transferrin measurements observed after 15 months.

    Product
    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2931-2018·2018-09-05

    CSL Behring Recalls N Latex CDT Kits Due to Measurement Bias

    CSL Behring is recalling N Latex CDT Kits because they may produce inaccurate results that are approximately 15% lower than expected.

    Product
    N Latex CDT Kit
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0191-2018·2017-12-06

    Siemens N/T Protein Control SL Recalled for Inaccurate Ceruloplasmin Values

    CSL Behring GmbH is recalling Siemens N/T Protein Control SL products because they were incorrectly value-assigned, leading to biased ceruloplasmin test results.

    Product
    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0190-2018·2017-12-06

    Siemens N Protein Standard SL Recalled for Inaccurate Ceruloplasmin Calibration

    CSL Behring GmbH is recalling Siemens N Protein Standard SL and N/T Protein Controls SL due to incorrect value assignments that cause negative bias in Ceruloplasmin test results.

    Product
    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2241-2016·2016-07-27

    CSL Behring Recalls Dimension Vista Homocysteine Reagent Cartridges

    CSL Behring is recalling 898 units of Dimension Vista Homocysteine Flex Reagent Cartridges because opened lots show reduced stability and do not meet the 7-day claim.

    Product
    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    36 states