FDA Device recall Z-2249-2013
ACL TOP 300 and ACL TOP 300 CTS (Japan)
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of ACL TOP 300 and ACL TOP 300 CTS (Japan) 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-2249-2013 |
| 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 300 and ACL TOP 300 CTS (Japan); PN 0000280060 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: 12060256, Jun 2012; End SN and Date: 13070837, July 2013 and Start SN and Date: 11120131J, Dec 2011; End SN and Date: 13060320J, Jun2013 |
|---|
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-2249-2013%22
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