Sample Probe (Beckman Coulter) – Manufacturing Defect (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.

Recommended Action

Per FDA guidance

An "URGENT MEDICAL DEVICE RECALL" dated 4/24/2025 were mailed and emailed to customers on 4/30/2025 who were asked to do the following: - Check the analyzers, which meet the conditions below: a) Analyzers whose Serial No. is from 2023070718 to 2025021482. b) Analyzers whose sample probe has been replaced since July 1, 2023. - For analyzers that meet either of the above criteria, remove the sample probe from the instrument in accordance with IFU Section 6, Maintenance / As needed Maintenance/Replace a Sample or Reagent Probe. And then, check the groove on the head of the removed sample probe. a) If it has a marking line, continue to use. b) If it does not have a marking line, replace the sample probe with a probe not included in the impacted sample probe lot numbers. - Dispose impacted probes to ensure it is not used. Also check the sample probes included in the maintenance kits. Contact your firm representative for replacements. - If all the results of the actions above show only defective sample probes on your analyzers and in stock, stop measuring the assay items which sample volume is 2.0 microliters or less and contact your BEC representative for a replacement. - Firm recommends that customers should share the content of this letter with their laboratory and/or medical director to assess if a retrospective review of the patient results is needed. - Complete and return the response form via email to beckmanresponse@abcoinc.com -Complete and return the Replacement Order Form to askbeckman@beckman.com or fax to (866) 294-7850 OR Call Client Services at (800) 526-3821 If you have any questions regarding this notice, please contact the firm's Customer Support Center: From firm website: http://www.beckmancoulter.com For customers in the United States, if you need replacement product: Complete Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR Call Client Services at (800) 526-3821.