ACL TOP — Class II medical device recall Z-2244-2013
Terminated recall by Instrumentation Laboratory Co., reported 2013-09-25, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
| Recall number | Z-2244-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2013-07-19 |
| Classified | 2013-09-18 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-10-27 |
| Distributed | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, ES, FI, FR, GR, GT, HK, HU, IE, IL, IN, IT, JP, KR, KW, LU, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, VE, VN, ZA |
| Quantity | 929 |
| Serial numbers | 02110101 |
Product
ACL TOP (Base); PN 0000280000 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
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
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-2244-2013. 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.