Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported February 3, 2021
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.
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…
Fujifilm Medical Systems U.S.A., Inc. recalled Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C o… - a low-severity action.
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C o… was recalled by Fujifilm Medical Systems U.S.A., Inc. in February 3, 2021. Reason: FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all produc…. Check the official notice for the remedy. Verify recall #Z-0932-2021 with the FDA Devices before acting.
The recall
Fujifilm Medical Systems U.S.A., Inc. issued this low-severity FDA Devices recall-FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all produc….
- Low
- severity level
- Class III
- classification
- February 3, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0932-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0932-2021) was formally reported on February 3, 2021, with the manufacturer initiating the action on December 22, 2020. It is classified under Low severity (Class III), with a current status of Terminated. Fujifilm Medical Systems U.S.A., Inc. is listed as the recalling firm, operating out of Lexington, MA. Federal records list the affected scope as 10 boxes (4 units per box).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of MO, OR, MD, PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10 boxes (4 units per box)
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0932-2021 |
| Date reported | February 3, 2021 |
| Date initiated | December 22, 2020 |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Firm location | Lexington, MA |
| Affected scope | 10 boxes (4 units per box) |
| Distribution | US Nationwide distribution including in the states of MO, OR, MD, PA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0932-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 10 boxes (4 units per box).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Low. Recall number: Z-0932-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of MO, OR, MD, PA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0932-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 3, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.