ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1 — Class II medical device recall Z-1014-2022
Ongoing recall by Instrumentation Laboratory, reported 2022-05-04, distributed nationwide. Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality con
| Recall number | Z-1014-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2022-02-22 |
| Classified | 2022-04-28 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BM, BR, CA, CH, CL, CN, CO, CR, CZ, DE, EC, ES, FR, GB, GR, GT, GY, HK, HU, ID, IE, IL, IN, IT, JP, KR, KW, LB, LT, LU, MA, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, PY, RO, RS, RU, SA, SG, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN |
| UPC / GTIN / UDI-DI | 08426950453499, 08426950556916, 08426950729242, 08426950784081, 08426950928003, 08426950928027, 08430793045476 |
| Model numbers | 00000280060, 00000280060R, 08426950556916, 1.ACLTOP, 300CTS |
Product
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097
Reason for recall
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
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-1014-2022. 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.