Alinity hq Analyzer — Class II medical device recall Z-2681-2024
Ongoing recall by Abbott Laboratories, reported 2024-08-28, distributed nationwide. 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately f
| Recall number | Z-2681-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Santa Clara, CA, United States |
| Recall initiated | 2024-06-14 |
| Classified | 2024-08-16 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BE, BG, BR, CA, CH, CL, CO, CZ, DE, DK, EG, ES, FR, GB, GR, HK, HN, HR, HU, ID, IN, IT, JM, JO, JP, KR, KW, KY, LB, LT, MX, MY, NL, NO, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SI, TH, TR, TT, UY, VN, ZA |
| Quantity | 816 |
| UPC / GTIN / UDI-DI | 00380740138851 |
| Serial numbers | HQ00105, HQ00108, HQ00117, HQ00118, HQ00119, HQ00120, HQ00126, HQ00127, HQ00128, HQ00132, HQ00136, HQ00139, HQ00140, HQ00141, HQ00142, HQ00144, HQ00145, HQ00147, HQ00148, HQ00149, HQ00152, HQ00153, HQ00154, HQ00156, HQ00157 and 475 more |
| Model numbers | 09P68-01 |
Product
Alinity hq Analyzer, REF: 09P68-01
Reason for recall
1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts
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-2681-2024. 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.