Lower riskMedical device recall · FDA · Published December 22, 2020
Fujifilm Wako HDL-C/LDL-C Calibrator Recall: Incorrect Labeling May Cause Wrong Test
Fujifilm recalls Wako HDL-C/LDL-C Calibrator (Lot EL62:9) due to incorrect concentration values on labels, which may lead to inaccurate cholesterol test results. Affected units should be checked for the specific lot number.
FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.
Take action
Contact the company
📍Recalling firmFujifilm Medical Systems U.S.A., Inc.81 Hartwell Ave Ste 300 · Lexington, MA 02421-3160
“Fujifilm Wako HDL-C/LDL-C Calibrator Recall: Incorrect Labeling May Cause Wrong Test.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63627-fujifilm-wako-hdl-c-ldl-c-calibrator-recall-incorrect-labeling. Based on FDA recall #Z-0932-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0932-2021%22&limit=1).
The FDA announced on Dec. 22, 2020, that Fujifilm Medical Systems U.S.A., Inc. is recalling Wako HDL-C/LDL-C Calibrator units due to incorrect concentration values printed on the bottle label for Lot EL629. GovInfoNow's records show this voluntary Class III recall was terminated.
How to tell if you have it
Brand: Fujifilm
Product: Wako HDL-C/LDL-C Calibrator
Lot code: EL629
Model number: 990-28011
The hazard
According to the FDA, incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result in incorrect results when used in testing.
Context
GovInfoNow's records show Fujifilm Medical Systems U.S.A., Inc. has 13 other recalls on record since June 15, 2017. Other recent recalls of similar products include Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (Dec. 11, 2025), Fujirebio Lumipulse Amyloid Plasma Controls Recall (Dec. 11, 2025) and Fujirebio Lumipulse pTau 217 Plasma Controls Recall (Dec. 11, 2025).
How to tell if you have this one
Check the label for the lot number EL629. The product is a Wako HDL-C/LDL-C Calibrator used with Wako L-Type HDL-C or L-Type LDL-C for cholesterol testing.
Brand
Fujifilm
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Label for Lot Number
Look for the lot number EL629 on the calibrator's label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of MO, OR, MD, PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maryland, Missouri, Oregon, Pennsylvania.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0932-2021 (December 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0932-2021 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.