Medline Hemoglobin Control Kits: Shipment Compromise Risk
Medline recalls hemoglobin control kits for potential shipment damage. These kits help monitor Hemocue analyzers; affected lots include 072564. No action needed as the hazard is shipping-related.
Lower-risk recall
Product was compromised during shipment.
Contact the company
What happened, in plain English
Medline is recalling hemoglobin control kits used with Hemocue analyzers due to potential damage during shipping. This issue doesn't affect safety but may cause inaccurate test results if the kit is damaged. Read more at govinfonow.com/recall/63350-medline-hemoglobin-control-kits-shipment-compromise-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63350-medline-hemoglobin-control-kits-shipment-compromise-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1249-2021
Cite this page
“Medline Hemoglobin Control Kits: Shipment Compromise Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63350-medline-hemoglobin-control-kits-shipment-compromise-risk. Based on FDA recall #Z-1249-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2021%22&limit=1).
Why it’s dangerous
The kits were damaged during shipping, which could lead to inaccurate hemoglobin test results. However, this does not pose a direct safety risk to users.
Who’s affected
Users of Hemocue hemoglobin analyzers who purchased the specific kit lot 072564. Most at risk are healthcare professionals using these kits for routine quality checks.
How to tell if you have this one
Check for the lot number 072564 on the kit packaging. The product is used with Hemocue hemoglobin analyzers for quality control checks.
- Brand
Medline- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for the lot number 072564 on the product packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution in the states of KY, PA, OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Kentucky, Ohio, Pennsylvania.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1249-2021 (January 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1249-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.