Beckman Coulter — Class II medical device recall Z-2976-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2026-08-26, distributed nationwide. Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which ma
| Recall number | Z-2976-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2026-07-13 |
| Classified | 2026-08-17 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| Quantity | 55 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00842768023293 |
| Lot numbers | 2597, 2627, 2709 |
| Model numbers | OSR4Q229 |
Product
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Reason for recall
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
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-2976-2026. 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.