Access Hybritech p2PSA reagent — Class II medical device recall Z-2043-2023
Ongoing recall by Beckman Coulter, Inc., reported 2023-07-05, distributed in CA, CO, CT, FL, GA, IL, IN, MA…. Reagent lot numbers include an insufficient concentration of blocking reagent.
| Recall number | Z-2043-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2023-05-17 |
| Classified | 2023-06-29 |
| Reported by FDA | 2023-07-05 |
| Distributed | CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, WA |
| Countries outside the US | AT, AU, BE, BR, CH, CN, CZ, DE, ES, FR, HK, IN, IT, JP, KR, LT, MX, PT, RS, RU, SG, SK, TW, VN |
| Quantity | 987 kits |
| UPC / GTIN / UDI-DI | 15099590204112, 15099590211325 |
| Lot numbers | 234133, 234134, 234320 |
| Model numbers | A49752, B03704 |
| Expiration dates | 2023-06-30, 2023-07-31 |
Product
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Reason for recall
Reagent lot numbers include an insufficient concentration of blocking reagent.
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-2043-2023. 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.