ClearanceBrief
Recall Z-0932-2022 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

MEDLINE INDUSTRIES, LP - Northfield

Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

DateMar 8, 2022
StatusTerminated
ReasonProduct was improperly store which may cause a delay in results.
Root causeStorage
ActionConsignees were notified via first class mail on March 08, 2022. Consignees are responsible for initiating sub-recalls, where necessary. Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their
Quantity45 ea
DistributionUS distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.