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 reagent
    • REF B03704 and REF A49752
Lot codes and dates

3 of 3 products

Products covered by this recall
#BarcodesProduct as published
115099590211325Lot #234320, exp. 7/31/2023, UDI (01)15099590211325(17)230731(11)220731(10)234320
215099590211325Lot #234134, exp. 6/30/2023, UDI (01)15099590211325(17)230630(11)220630(10)234134
315099590204112and 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.