RegWardenFDA facility compliance records
Facility

HYPHEN BIOMED SASU

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

Activity 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)

Devices registered here (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.

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. “HYPHEN BIOMED SASU (FEI 3004434070) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004434070-hyphen-biomed-sasu/

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