RegWardenFDA facility compliance records
Company

Primus

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

Recalls by year

FDA actions on record by year2020: 1 recalls; 2021: 1 recalls201720182019120201202120222023202420252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IIITerminated2021-10-05
    The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further te…
  • Class IITerminated2020-10-09
    The product did not receive pre-market approval or clearance.

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. “Primus — 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-9005293-primus/

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