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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON Systems Cholesterol (CHOL) Reagent

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  Class 2 Device Recall SYNCHRON Systems Cholesterol (CHOL) Reagent see related information
Date Initiated by Firm November 10, 2021
Create Date December 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-0399-2022
Recall Event ID 89035
510(K)Number K971505  
Product Classification Enzymatic esterase--oxidase, cholesterol - Product Code CHH
Product SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Code Information Lot: M106450, UDI: 15099590575113
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Rachel Davison
952-368-7885
Manufacturer 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.
FDA Determined
Cause 2		 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 information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 5) Complete and return the Response Form. For customers in the United States, if you need replacement product, complete the Replacement Order Form.
Quantity in Commerce 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, 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CHH and Original Applicant = BECKMAN INSTRUMENTS, INC.
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