FDA recall Z-1135-2021

Medline Industries Inc · Class III · device

Product

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.

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-01-15
Report date
2021-03-03
Termination date
2023-01-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1135-2021