FDA Device recall Z-0399-2022
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
- FDA Device
- Class II
- ongoing
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0399-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-10 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Reason
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.
Identifiers
| code_info | Lot: M106450, UDI: 15099590575113 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0399-2022%22
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