FDA Device recall Z-2246-2013
ACL TOP CTS
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of ACL TOP CTS by Instrumentation Laboratory, citing potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2246-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-19 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instrumentation Laboratory |
| Distribution | 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 |
Product
ACL TOP CTS; PN 0000280020 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
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Identifiers
| code_info | Start SN and Date: 06020101, Feb 2006; End SN and Date: 10080662, Aug 2010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2246-2013%22
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