Alinity m System — Class II medical device recall Z-1602-2024
Ongoing recall by Abbott Molecular, Inc., reported 2024-05-01, distributed nationwide. The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention
| Recall number | Z-1602-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2024-03-20 |
| Classified | 2024-04-19 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, EE, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IT, JP, KE, KR, LU, LV, MA, MX, MY, NG, NL, NO, NZ, PA, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TR, TW, VN, ZA |
| Quantity | 1,012 units |
| UPC / GTIN / UDI-DI | 00884999048034 |
| Model numbers | 08N53-002 |
Product
Alinity m System, Part Number: 08N53-002
Reason for recall
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
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-1602-2024. 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.