Reported Oct 13, 2021 · Ongoing
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
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. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
- Lot codes and dates
32 of 32 products · 32 lot codes
Recalled lot codes, grouped by product number Lot Number UDI Code 921491(01)15099590693183(17)201130(11)191201(10)921491
921638(01)15099590693183(17)201231(11)200101(10)921638
921631(01)15099590693183(17)210131(11)200201(10)921631
921750(01)15099590693183(17)210131(11)200201(10)921750
921805(01)15099590693183(17)210228(11)200229(10)921805
921831(01)15099590693183(17)210331(11)200331(10)921831
921943(01)15099590693183(17)210430(11)200430(10)921943
922000(01)15099590693183(17)210531(11)200531(10)922000
922039(01)15099590693183(17)210630(11)200630(10)922039
922040(01)15099590693183(17)210731(11)200731(10)922040
- Amount recalled
- 293,640 kits
Where it was sold
Why it was recalled
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.
This product could cause temporary or reversible health problems — stop using it.
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