FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: 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.
- Recall number
- Z-0932-2021
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-12-22
- Posted
- not on file
- Terminated
- 2021-07-20
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- On, 12/22/2020, FUJIFILM issued an Urgent Medical Device Removal notice to customers via email. 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.
- Quantity
- 10 boxes (4 units per box)
- Distribution
- US Nationwide distribution including in the states of MO, OR, MD, PA.
- Lot, serial or model codes
- Lot EL629, Model 990-28011
- 510(k) numbers
- ["K001005"]
- PMA numbers
- not on file
- Product code
- JIS
- Firm FEI
- 1000513161
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28