Recall Z-0297-2021— Medline Industries Inc

Name: FDA recall Z-0297-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-01

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2020-10-01, terminated 2021-05-03. It names one FDA 510(k) clearance: K033383. Product: The Quidel Triage BNP Calibrators. Reason: Product compromised during shipment..

Recalling firm: Medline Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2020-10-01
Terminated: 2021-05-03
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K033383 — TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200Biosite Incorporated·cleared 2003-12-23

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

The Quidel Triage BNP Calibrators

Reason for recall

Product compromised during shipment.

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