Recall Z-0399-2022 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Beckman Coulter Inc.
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
| Date | Nov 10, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/10/21 recall notices were sent to customers. Customers with questions are encouraged to contact the Customer Support Center: http://www.beckmancoulter.com, 1-800-854-3633 in the United States and Canada. Customers were asked to take the following action: 1) Discontinue use of affected cholesterol reagent and follow the product replacement instructions. 2) Review the Safety Data Sheet (SDS) and discard according to your laboratory s Standard Operating Procedures and/or your local regulations. 3) Retrospective review is left to the discretion of the Laboratory Director. 4) Share this infor |
| Quantity | 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, Washington, New Mexico, Iowa ,Nebraska, Idaho, Michigan, Maryland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971505 | SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT Beckman Instruments, Inc., Jun 11, 1997 |