Recall Z-0321-2021— Primus Corporation

Name: FDA recall Z-0321-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-09

Class II · Terminated

Class II FDA medical device recall by Primus Corporation, initiated 2020-10-09, terminated 2021-11-04. It names one FDA 510(k) clearance: K955283. Product: Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation. Reason: The product did not receive pre-market approval or clearance..

Recalling firm: Primus Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-10-09
Terminated: 2021-11-04
Firm location: Kansas City, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K955283 — PRIMUS VARIANT SYSTEM PVS99Primus Corp.·cleared 1996-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

Reason for recall

The product did not receive pre-market approval or clearance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.