CLASS III Device recall · Reported 3 Feb 2021 · FDA Enforcement Report
Wako Hdl-c/Ldl-c Calibrator recalled by Fujifilm Medical Systems U.S.A
Fujifilm Medical Systems U is recalling Wako Hdl-c/Ldl-c Calibrator, distributed nationwide in the US. The recall was initiated on 22 Dec 2020 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0932-2021
- FDA event ID
- 87098
- Recalling firm
- Fujifilm Medical Systems U, Lexington, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Dec 2020
- FDA classified
- 28 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2020 | Recall initiated by company | |
| 28 Jan 2021 | Classified by FDA | +37 days |
| 3 Feb 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the states of MO, OR, MD, PA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot EL629, Model 990-28011
Where was it sold?
US Nationwide distribution including in the states of MO, OR, MD, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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