Recall Z-0399-2022— Beckman Coulter Inc.

Name: FDA recall Z-0399-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-10

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-11-10. It names one FDA 510(k) clearance: K971505. 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-11-10
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K971505 — SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENTBeckman Instruments, Inc.·cleared 1997-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.