Access Hybritech p2PSA reagent recall
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Why was Access Hybritech p2PSA reagent recalled?
Reagent lot numbers include an insufficient concentration of blocking reagent.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 987 kits
- Distribution
- Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, and WA. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Lithuania, Macao, Mexico, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, and Vietnam.
- Recall date
- July 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)