—#185587

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.

FDA product code: JPK — Mixture, Hematology Quality Control
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K853776
Affected lot / code info: lot number 072564

Why it was recalled

Product was compromised during shipment.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the states of KY, PA, OH.

Timeline

Recall initiated: 2021-01-25
Terminated: 2023-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185587. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.