Kamiya K-Assay Multi-Analyte Calibrator Recall: Incorrect AlAT Values
Kamiya recalls specific lots of K-Assay Multi-Analyte Calibrator due to incorrect AlAT calibrator values in package inserts, potentially affecting lab test accuracy.
Lower-risk recall
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
Contact the company
What happened, in plain English
Kamiya is recalling certain lots of their K-Assay Multi-Analy: Calibrator because the AlAT calibrator values listed in the package inserts were incorrect. This could lead to inaccurate lab test results if the recalled calibrators are used. Read more at govinfonow.com/recall/73391-kamiya-k-assay-multi-analyte-calibrator-recall-incorrect-alat-values.
Source Summary by GovInfoNow · govinfonow.com/recall/73391-kamiya-k-assay-multi-analyte-calibrator-recall-incorrect-alat-values · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3138-2017
Cite this page
“Kamiya K-Assay Multi-Analyte Calibrator Recall: Incorrect AlAT Values.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73391-kamiya-k-assay-multi-analyte-calibrator-recall-incorrect-alat-values. Based on FDA recall #Z-3138-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3138-2017%22&limit=1).
Why it’s dangerous
The calibrator values in the package inserts for specific lots were incorrect. This could result in inaccurate lab test results if the recalled calibrators are used in immunoturbidimetric assays.
Who’s affected
Lab users who purchased the K-Assay Multi-Analyte Calibrator with lot numbers N653, N654, D755, D647, F648, F649, G650, or J651 are affected. Those performing immunoturbidimetric assays using this calibrator are most at risk.
How to tell if you have this one
Check the lot number on the K-Assay Multi-Analyte Calibrator packaging. Affected lots include N653, N654, D755, D647, F648, F649, G650, and J651.
- Brand
Kamiya- Category
Medical device
What to do — step by step
Check Lot Number
Identify the lot number on the K-Assay Multi-Analyte Calibrator packaging to determine if it is affected.
Where it went and when
Where it was distributed
Distributed in 14 states, and outside the U.S.
FDA distribution: “Worldwide Distribution - US including FL, CA, WA, OH, IA, IL, NJ, NY, NC, MA, TX, CT, MD, VA, Internationally to TN, Czech Republic, Taiwan, Dominican Republic, Switzerland, China, and Jamaica” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, Florida, Illinois, Iowa, Maryland, Massachusetts, New Jersey, New York, North Carolina, Ohio, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- 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-3138-2017 (July 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3138-2017 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.