Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a… — Class II medical device recall Z-2391-2012
Terminated recall by Instrumentation Laboratory Co., reported 2012-09-26, distributed nationwide. Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
| Recall number | Z-2391-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2012-08-03 |
| Classified | 2012-09-14 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2015-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CH, CL, CN, DE, DK, ES, FI, FR, GB, HK, HU, IE, IL, IN, IT, JP, KR, LU, MX, MY, NL, NO, NZ, PA, PE, PL, PT, RO, SA, SE, SK, TH, TR, TW, UY, VN, ZA |
| Quantity | 2,171 units |
Product
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Reason for recall
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
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-2391-2012. 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.