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U.S. Department of Health and Human Services

Class 2 Device Recall QCHGB HEMOGLOBIN CONTROL

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 Class 2 Device Recall QCHGB HEMOGLOBIN CONTROLsee related information
Date Initiated by FirmJanuary 25, 2021
Create DateMarch 12, 2021
Recall Status1 Terminated 3 on January 09, 2023
Recall NumberZ-1249-2021
Recall Event ID 87232
510(K)NumberK853776 
Product Classification Mixture, hematology quality control - Product Code JPK
ProductRNA 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.
Code Information lot number 072564
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		Product was compromised during shipment.
FDA Determined
Cause 2		Process control
ActionThe firm notified their consignees by letter on 01/25/2021. The letter explained the problem and requested destruction of the product.
Quantity in Commerce4 units
DistributionUS Nationwide distribution in the states of KY, PA, OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JPK
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