Medline Industries Inc recalls S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the…

Recall date

January 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1135-2021

FDA classification

Class III

Brand / firm

Medline Industries Inc

Sold / distributed

US Nationwide distribution in the states of MS, OH, IL.

Why it was recalled

Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.