Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 29, 2021
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing cali…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Inc. recalled SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 - a moderate-severity action.
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 was recalled by Beckman Coulter Inc. in December 29, 2021. Reason: Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Lo…. Check the official notice for the remedy. Verify recall #Z-0399-2022 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this moderate-severity FDA Devices recall-Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Lo….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- December 29, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0399-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0399-2022) was formally reported on December 29, 2021, with the manufacturer initiating the action on November 10, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 1433.
The documented reason for this recall is: Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartme… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of Louisiana, Ohio, North Carolina, California, South Carolina, Oklahoma, Pennsylvania, New York, Florida, New Jersey, Wisconsin, Alabama, Texas, Georgia, Maine, North Dakota, Vi…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1433
Related Recalls
6
3 from same agency
Product description
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Reason for recall
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0399-2022 |
| Date reported | December 29, 2021 |
| Date initiated | November 10, 2021 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 1433 |
| Distribution | US Nationwide distribution in the states of Louisiana, Ohio, North Carolina, California, South Carolina, Oklahoma, Pennsylvania, New York, Florida, New Jersey, Wisconsin, Alabama, Texas, Georgia, Maine, North Dakota, Virginia, Kansas, Wash… |
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-0399-2022) 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? ▼
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825. Recalled by Beckman Coulter Inc.. Units affected: 1433.
Why was this product recalled? ▼
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 29, 2021. Severity: Moderate. Recall number: Z-0399-2022.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of Louisiana, Ohio, North Carolina, California, South Carolina, Oklahoma, Pennsylvania, New York, Florida, New Jersey, Wisconsin, Alabama, Texas, Georgia, Maine, North Dakota, Virginia, Kansas, Washington, New Mexico, Iowa ,Nebraska, Idaho, Michigan, Maryland, Arizona, Hawaii, Missouri, Oregon, Mississippi, Rhode Island, Alaska, Tennessee, Illinois, Delaware, Kentucky, Arkansas, West Virginia, Massachusetts. OUS: India, South Africa, Saudi Arabia, Canada, Lebanon, Singapore, Philippines, Thailand.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0399-2022) 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 December 29, 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.