CLASS II Device recall · Reported 24 Mar 2021 · FDA Enforcement Report
Rna Medical, Qchgb Hemoglobin Control, Multi recalled
Medline Industries is recalling Rna Medical, Qchgb Hemoglobin Control, Multi, distributed nationwide in the US. The recall was initiated on 25 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1249-2021
- FDA event ID
- 87232
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jan 2021
- FDA classified
- 12 Mar 2021
- Reported
- 24 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 25 Jan 2021 | Recall initiated by company | |
| 12 Mar 2021 | Classified by FDA | +46 days |
| 24 Mar 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was compromised during shipment.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of KY, PA, OH.
Questions about this recall
Why was it recalled?
Product was compromised during shipment.
Which lots are affected?
lot number 072564
Where was it sold?
US Nationwide distribution in the states of KY, PA, OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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