Alinity s System REF 06P16-01 — Class II medical device recall Z-2276-2021
Ongoing recall by Abbott Laboratories, Inc, reported 2021-08-18, distributed nationwide. A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/o
| Recall number | Z-2276-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2021-07-12 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BH, BR, CN, CO, DE, EG, ES, GB, GR, HK, HR, HU, IE, IL, IR, IT, JO, KW, MX, NL, PK, PL, PT, RS, SA, SI, UA, ZA |
| Quantity | 260 systems |
| Reason classes | software |
| Serial numbers | AS1001 |
| Model numbers | 06P16-01 |
Product
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Reason for recall
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
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-2276-2021. 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.