Medline Diluent Recall: False test results due to shipment compromise
Medline recalls Diluent products that may cause false negative or positive test results due to shipment damage. Affected lots include 163878, 192821, 191991, 160795. Consumers should check their lot numbers.
Lower-risk recall
Possible false negative or false positive results due to the product being compromised during shipment.
Contact the company
What happened, in plain English
Medline is recalling Diluent products that may cause false test results if they were damaged during shipping. This could lead to incorrect health assessments when used with Stat-Site or KetoSite tests. Read more at govinfonow.com/recall/63095-medline-diluent-recall-false-test-results-due-to-shipment-compromise.
Source Summary by GovInfoNow · govinfonow.com/recall/63095-medline-diluent-recall-false-test-results-due-to-shipment-compromise · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1407-2021
Cite this page
“Medline Diluent Recall: False test results due to shipment compromise.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63095-medline-diluent-recall-false-test-results-due-to-shipment-compromise. Based on FDA recall #Z-1407-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1407-2021%22&limit=1).
Why it’s dangerous
The Diluent product may become compromised during shipping, leading to inaccurate test results. This could cause false negatives or positives when used with Stat-Site test strips or KetoSite test cards.
Who’s affected
People who use Diluent for home blood tests with Stat-Site or KetoSite test strips. Those who have the specific lot numbers listed are most at risk.
How to tell if you have this one
Check the lot number on the Diluent product. Affected lots are 163878, 192821, 191991, and 160795. The product is intended for use with Stat-Site or KetoSite tests.
- Brand
Medline- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the Diluent product to see if it matches the affected lots: 163878, 192821, 191991, or 160795.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of Ohio.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1407-2021 (March 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1407-2021 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.