Recall Z-2245-2013
Instrumentation Laboratory Co. · initiated July 19, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ACL TOP 700; PN 0000280010 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.
Codes / lots: Start SN and Date: 09080100, Aug 2009 End SN and Date: 13070559, July 2013
Reason for recall
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
FDA-determined cause: Device Design
Action taken
Instrumentation Laboratory sent an Important Product Correction letter on July 19, 2013, to all affected customers. On July 23, 2013, the same communication was circulated by the IL International Group in Milan, Italy to the affected international distributors and dealers. The interim field notification was followed by the release of corrective Software V5.1.0 and Parameters P-16.3.00 (Phase II) on September 30,2013. Consignees were advised of a potential carryover issue and a workaround was provided. Consignees were asked to fax the Mandatory Response Tracking Form to 781-861-4207 or email to ra-usa.ilww.com For technical questions customers were instructed to contact the IL Technical Support Center at 1-800-678-0710, option 2. For product availability questions, customers were instructed to contact their IL Customer Service Representative at 1-800-955-9525, Option #2. For questions regarding this recall call 781-861-4467.
Details
- Recall number
- Z-2245-2013
- Initiated
- July 19, 2013
- Posted by FDA
- September 18, 2013
- Terminated
- October 27, 2014
- Product code
- GKP – Instrument, Coagulation, Automated
- Quantity
- 311
- Distribution
- Worldwide Distribution - USA including 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, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland…
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2244-2013 Class II | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2246-2013 Class II | ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2247-2013 Class II | ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2248-2013 Class II | ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2249-2013 Class II | ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2250-2013 Class II | ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |