Wako HDL-C/LDL-C Calibrator — Class III medical device recall Z-0932-2021
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2021-02-03, distributed nationwide. FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product
| Recall number | Z-0932-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Lexington, MA, United States |
| Recall initiated | 2020-12-22 |
| Classified | 2021-01-28 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2021-07-20 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | EL629 |
| Model numbers | 990-28011 |
Product
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0932-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.