Access Substrate — Class II medical device recall Z-1376-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-04-03, distributed nationwide. On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lo
| Recall number | Z-1376-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-02-07 |
| Classified | 2024-03-25 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CN, CO, CR, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 725,568 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 15099590229986 |
| Lot numbers | 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338538, 338587 |
| Model numbers | 81906 |
Product
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Reason for recall
On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cause some patient results reporting delay but will not cause any errorreous results. However, because labs are required to have redundancy such that delay would not significantly impact clinical management and because the defect is easily recognized by the user, the probability of harm is remote.
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-1376-2024. 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.