Recall Z-1249-2021

Medline Industries Inc · initiated January 25, 2021

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.

Codes / lots: lot number 072564

Reason for recall

Product was compromised during shipment.

FDA-determined cause: Process control

Action taken

The firm notified their consignees by letter on 01/25/2021. The letter explained the problem and requested destruction of the product.

Details

Recall number
Z-1249-2021
Initiated
January 25, 2021
Terminated
January 9, 2023
Product code
JPK – Mixture, Hematology Quality Control
Quantity
4 units
Distribution
US Nationwide distribution in the states of KY, PA, OH.
Recalling firm
Medline Industries Inc, Northfield, IL

Official FDA recall record