SYNCHRON Systems Cholesterol — Class II medical device recall Z-0399-2022
Ongoing recall by Beckman Coulter Inc., reported 2021-12-29, distributed nationwide. Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low
| Recall number | Z-0399-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-11-10 |
| Classified | 2021-12-20 |
| Reported by FDA | 2021-12-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IN, LB, MX, PH, SA, SG, TH, ZA |
| Quantity | 1,433 |
| Reason classes | specification failure, device malfunction |
| UPC / GTIN / UDI-DI | 15099590575113 |
| Lot numbers | M106450 |
| Model numbers | 467825 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0399-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.