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Terminated

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 Recall Z-1249-2021 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeJPK
Date Initiated2021-01-25
Date Terminated2023-01-09
Product Quantity4 units

Reason for Recall

Product was compromised during shipment.

Firm Action

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

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K853776MSI-HB HEMOGLOBIN CONTROLMedical Specialties, Inc. · 1985-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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