Recall Z-2043-2023— Beckman Coulter, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2023-05-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Access Hybritech p2PSA reagent, REF B03704 and REF A49752.. Reason: Reagent lot numbers include an insufficient concentration of blocking reagent..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-17
- Firm location
- Chaska, MN, United States
Product description
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Reason for recall
Reagent lot numbers include an insufficient concentration of blocking reagent.
Data sourced from openFDA. This site is unofficial and independent of the FDA.