RegWardenFDA facility compliance records
Company

HYPHEN BIOMED

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

Recalls by year

FDA actions on record by year2011: 1 recalls; 2018: 1 recalls1’11’12’13’14’15’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2018-02-05
    Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
  • Class IITerminated2011-11-09
    A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.

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. “HYPHEN BIOMED — 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-9067801-hyphen-biomed/

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