ACL ELITE Refurbished-Analyzer designed specifically for clinical use… — Class II medical device recall Z-1306-2023
Ongoing recall by Instrumentation Laboratory, reported 2023-04-05, distributed nationwide. Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite
| Recall number | Z-1306-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2023-02-03 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BR, CA, CH, CN, CO, CZ, DE, DZ, EG, ES, FI, FR, GB, GH, GR, HK, HU, ID, IE, IN, IR, IT, JO, JP, KE, KR, LB, LK, LT, LV, MX, MY, PH, PL, RO, RS, SA, TH, TW, UA, UY, VN, ZA |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 08426950965572 |
| Serial numbers | 11121320R |
| Model numbers | 0000880311R |
Product
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
Reason for recall
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
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-1306-2023. 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.