Beckman Coulter, Inc. Access Hybritech p2PSA reagent, REF B03704 and REF A49752. Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Reagent lot numbers include an insufficient concentration of blocking reagent.

Recommended Action

Per FDA guidance

The recalling firm issued letters to U.S. consignees dated 5/15/2023 via first class mail and email on 5/17/2023. The letter described the issue, impact, and the action to be taken. The consignee was instructed to discontinue using the reagent lots that were listed and discard all remaining reagent packs from the lots. The letter was to be shared with the consignee laboratory and/or medical director regarding the need to review previous patient test results. The Beckman Coulter representative was to be contacted for replacement product requests. If the product was forwarded to another laboratory, the consignee is to provide them a copy of the letter. The consignee is requested to respond within 10 days of receipt of the letter either electronically or manually by completing the enclosed Response Form. The letter for the OUS consignees was dated 5/16/2023 and was similar to the letter for the U.S. consignees.

Distribution

As reported by FDA

CA, CO, CT, FL, GA, IL, IN, MA, MI, NE, NJ, NY, NC, OH, SC, TN, TX, UT, WA