Access hsTnI High Sensitivity Troponin I — Class II medical device recall Z-0032-2022
Ongoing recall by Beckman Coulter Inc., reported 2021-10-13, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may
| Recall number | Z-0032-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-08-09 |
| Classified | 2021-10-05 |
| Reported by FDA | 2021-10-13 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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 |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, BR, CA, CH, CN, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NO, NP, NZ, OM, PH, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, TH, TN, TR, TW, VN, ZA |
| Quantity | 293,640 kits |
| UPC / GTIN / UDI-DI | 15099590693183 |
| Model numbers | B52699 |
Product
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0032-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.