🔍 RecallPedia

Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

Class I - Dangerous
🏥 Medical Devices Recalled: May 17, 2023 Beckman Coulter Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot #234320, exp. 7/31/2023, UDI (01)15099590211325(17)230731(11)220731(10)234320; Lot #234134, exp. 6/30/2023, UDI (01)15099590211325(17)230630(11)220630(10)234134; and Lot #234133, exp. 6/30/2023, UDI (01)15099590204112(17)230630(11)220630(10)234133.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Beckman Coulter, Inc.
Reason for Recall:
Reagent lot numbers include an insufficient concentration of blocking reagent.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

Product Codes/Lot Numbers:

Lot #234320, exp. 7/31/2023, UDI (01)15099590211325(17)230731(11)220731(10)234320; Lot #234134, exp. 6/30/2023, UDI (01)15099590211325(17)230630(11)220630(10)234134; and Lot #234133, exp. 6/30/2023, UDI (01)15099590204112(17)230630(11)220630(10)234133.

Distribution:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2043-2023

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