Sekisui Diagnostics Acetaminophen L3K Recall: False Lipase Results Risk
Sekisui Diagnostics recalls acetaminophen L3K reagents due to potential false lipase results in lab tests. Affected units include all lots of Sekure Chemistry Acetaminophen L3K Ref. 506-30.
Lower-risk recall
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
Contact the company
What happened, in plain English
Sekisui Diagnostics is recalling its Acetaminophen L3K reagents (Ref. 506-30) because improper use with certain analyzers can cause false high lipase readings. This could lead to incorrect lab results affecting patient care. Read more at govinfonow.com/recall/73388-sekisui-diagnostics-acetaminophen-l3k-recall-false-lipase-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73388-sekisui-diagnostics-acetaminophen-l3k-recall-false-lipase-results-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3118-2017
Cite this page
“Sekisui Diagnostics Acetaminophen L3K Recall: False Lipase Results Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73388-sekisui-diagnostics-acetaminophen-l3k-recall-false-lipase-results-risk. Based on FDA recall #Z-3118-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3118-2017%22&limit=1).
Why it’s dangerous
When Sekisui ACTH reagent is carried over from previous tests into the BEC AU 680 analyzer, it can cause the lipase test results to be falsely elevated. This may lead to incorrect patient diagnoses or treatments.
Who’s affected
Laboratory users who have the Sekure Chemistry Acetaminophen L3K reagent (Ref. 506-30) are affected. The risk is highest for labs using this reagent with the BEC AU 680 analyzer.
How to tell if you have this one
Check for the product name 'Sekure Chemistry Acetaminophen L3K' with reference number 506-30. The manufacturer labels show Sekisui Diagnostics (UK) Limited and Sekisui Diagnostics P.E.I. Inc.
- Brand
Sekisui Diagnostics- Category
Medical device
What to do — step by step
Check Reagent Label
Look for the product name 'Sekure Chemistry Acetaminophen L3K' and reference number 506-30 on the label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distribution US nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 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.
Questions people ask
What should I do if I have this reagent?
The recall covers all lots of this reagent. Check the label to confirm and contact the manufacturer for further instructions.
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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-3118-2017 (July 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3118-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.