Recall Z-1407-2021— Medline Industries Inc

Name: FDA recall Z-1407-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-15

Class II · Ongoing

Class II FDA medical device recall by Medline Industries Inc, initiated 2021-03-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.. Reason: Possible false negative or false positive results due to the product being compromised during shipment..

Recalling firm: Medline Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-03-15
Firm location: Northfield, IL, United States

Product description

Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

Reason for recall

Possible false negative or false positive results due to the product being compromised during shipment.

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