ACL TOP Family 50 Series Models as follows: In vitro diagnostic… — Class II medical device recall Z-2578-2023
Ongoing recall by Instrumentation Laboratory, reported 2023-09-20, distributed nationwide. Sample misidentification could occur under specific conditions and patient management altered based on an inco
| Recall number | Z-2578-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2023-07-13 |
| Classified | 2023-09-12 |
| Reported by FDA | 2023-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FI, IE, LT, MT, QA, SE |
| UPC / GTIN / UDI-DI | 08426950729242, 08426950784050, 08426950784067, 08426950784074, 08426950784081, 08430793045476 |
| Model numbers | 00000280015, 00000280035, 00000280045, 00000280055, 00000280065, 00000280097 |
Product
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097
Reason for recall
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
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-2578-2023. 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.