Reported Jul 5, 2023 · Ongoing
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
Access Hybritech p2PSA reagentREF B03704 and REF A49752
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 15099590211325Lot #234320, exp. 7/31/2023, UDI (01)15099590211325(17)230731(11)220731(10)234320 2 15099590211325Lot #234134, exp. 6/30/2023, UDI (01)15099590211325(17)230630(11)220630(10)234134 3 15099590204112and Lot #234133, exp. 6/30/2023, UDI (01)15099590204112(17)230630(11)220630(10)234133. - Amount recalled
- 987 kits
Where it was sold
Why it was recalled
Reagent lot numbers include an insufficient concentration of blocking reagent.
This product could cause temporary or reversible health problems — stop using it.
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