Data Foundry

Medical device recalls 2021

RNA MEDICAL — Class II medical device recall Z-1249-2021

Terminated recall by Medline Industries Inc, reported 2021-03-24, distributed nationwide. Product was compromised during shipment.

Recall numberZ-1249-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedline Industries Inc, Northfield, IL, United States
Recall initiated2021-01-25
Classified2021-03-12
Reported by FDA2021-03-24
Terminated2023-01-09
DistributedNationwide (US)
Quantity4 units
Lot numbers072564

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.

Reason for recall

Product was compromised during shipment.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1249-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.