RegWardenFDA facility compliance records
Facility

HELENA LABORATORIES, CORP.

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

Activity by year

FDA actions on record by year2016: 3 recalls; 2017: 4 recalls, 1 inspections; 2018: 3 recalls; 2020: 1 recalls; 2021: 1 recalls; 2022: 1 recalls; 2023: 1 recalls320165201732018201912020120211202212023202420252026
  • Recalls (14)
  • Inspections (1)

Devices registered here (1)

  • Station, Pipetting And Diluting, For Clinical Use
    Product code JQW (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2750

Recalls & enforcement

20231 record
  • Class IIOngoing2023-05-02
    Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
20221 record
20211 record
20201 record
20183 records
  • Class IIOngoing2018-08-08
    The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
  • Class IIIOngoing2018-05-23
    Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
  • Class IIIOngoing2018-02-27
    Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
20174 records
  • Class IITerminated2017-12-07
    Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
  • Class IITerminated2017-07-21
    The plates do not have wells punched for the controls in the patient 1 area.
  • Class IITerminated2017-04-04
    Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.
  • Class IITerminated2017-02-24
    Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
20163 records
  • Class IIITerminated2016-11-07
    Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
  • Class IITerminated2016-10-14
    Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
  • Class IITerminated2016-04-20
    Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

FDA inspections (1)

  • NAI2017-07-14
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “HELENA LABORATORIES, CORP. (FEI 1000116989) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000116989-helena-laboratories-corp/

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