CLASS II ONGOING Device recall · Reported 29 Dec 2021 · FDA Enforcement Report
Synchron Systems Cholesterol (Chol) Reagent recalled by Beckman Coulter
Beckman Coulter is recalling Synchron Systems Cholesterol (Chol) Reagent, distributed nationwide in the US. The recall was initiated on 10 Nov 2021 and the FDA has classified it as Class II.
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-0399-2022
- FDA event ID
- 89035
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Nov 2021
- FDA classified
- 20 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Nov 2021 | Recall initiated by company | |
| 20 Dec 2021 | Classified by FDA | +40 days |
| 29 Dec 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Where it was distributed
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
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMissouri
Questions about this recall
Is Synchron Systems Cholesterol (Chol) Reagent recalled?
Yes. Beckman Coulter recalled Synchron Systems Cholesterol (Chol) Reagent on 10 Nov 2021. The recall is Class II and its status is Ongoing. Recall number Z-0399-2022.
Why was it 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 lots are affected?
Lot: M106450, UDI: 15099590575113
Where was it sold?
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
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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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