FDA Device recall Z-0032-2022
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
- FDA Device
- Class II
- ongoing
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0032-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-09 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV, WY |
Product
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Reason
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.
Identifiers
| code_info | Catalog Number:B52699 Lot Number / UDI Code: 921491 / (01)15099590693183(17)201130(11)191201(10)921491; 921638 / (01…Catalog Number:B52699 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; 922062 / (01)15099590693183(17)210731(11)200731(10)922062; 922145 / (01)15099590693183(17)210831(11)200831(10)922145; 922146 / (01)15099590693183(17)210930(11)200930(10)922146; 922338 / (01)15099590693183(17)210930(11)200930(10)922338; 922440 / (01)15099590693183(17)211031(11)201031(10)922440; 922545 / (01)15099590693183(17)211031(11)201031(10)92 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0032-2022%22
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