RegWardenFDA facility compliance records
Company

BIOCARE HOLDINGS, LLC

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

Recalls by year

FDA actions on record by year2018: 2 recalls; 2019: 1 recalls; 2021: 1 recalls; 2024: 1 recalls20172201812019202012021202220231202420252026
  • Recalls (5)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-09-25
    Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
  • Class IITerminated2021-02-25
    Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This …
  • Class IITerminated2019-10-10
    Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosi…
  • Class IITerminated2018-04-24
    Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
  • Class IITerminated2018-03-15
    Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “BIOCARE HOLDINGS, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9058052-biocare-holdings-llc/

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