Z-1249-2021Class II

RNA Medical, Qchgb Hemoglobin Control, Multi, Ref Qc Hgb -

Name: Z-1249-2021 RNA Medical, Qchgb Hemoglobin Control, Multi, Ref Qc Hgb -
Creator: Medline Industries Inc
Published: 2021-01-25
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-01-25 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient... on 2021-01-25. FDA classified it as Class II and gives the reason as "Product was compromised during shipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1249-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-25
Posted: 2021-03-12
Terminated: 2023-01-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: JPK Mixture, Hematology Quality Control
Reason for recall: Product was compromised during shipment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified their consignees by letter on 01/25/2021. The letter explained the problem and requested destruction of the product.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of KY, PA, OH.
Product codes and lots: lot number 072564

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1249-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1249-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-12

Product code JPK

K853776Class IIMsi-Hb Hemoglobin ControlMedical Specialties, Inc. / cleared 1985-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)