RegWardenFDA facility compliance records
Facility

Princeton BioMeditech Corp.

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2024: 1 recalls1’12’13’14’15’16’17’18’19’20’21’22’231’24’25’26
  • Recalls (2)

Devices registered here (1)

  • Antigens, All Groups, Streptococcus Spp.
    Product code GTY (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3740

Recalls & enforcement

  • Class IIOngoing2024-08-23
    This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced f…
  • Class IITerminated2012-03-09
    There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

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. “Princeton BioMeditech Corp. (FEI 3026478116) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3026478116-princeton-biomeditech-corp/

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