Recall Z-2065-2014
Instrumentation Laboratory Co. · initiated June 3, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Codes / lots: Start SN and Date: 09120101 Dec 2009 End SN and Date 14050368 May 2014
Reason for recall
Potential for sample misidentification.
FDA-determined cause: Device Design
Action taken
Consignees were notified via phone starting on June 3, 2014. On June 4, a USPS mailing was sent to all US/Canadian customers. On June 4, 2014, email notifications were sent to the IL Affiliates and International Distributors/Dealers (through the International Group) requesting them to translate the Field Safety Notice and provide notification to their customer base and secondary distributors. The Urgent Product Correction letter informs consignees of the issue and provides workaround instructions. Consignees are asked to complete a Mandatory Response Tracking Record and return it via Fax (781)861-4207 or email: ra-usa@ilww.com. For technical questions, consignees should contact the IL Technical Support Center at 1-800-678-0710.
Details
- Recall number
- Z-2065-2014
- Initiated
- June 3, 2014
- Posted by FDA
- July 16, 2014
- Terminated
- September 21, 2017
- Product code
- GKP – Instrument, Coagulation, Automated
- Quantity
- 266
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of 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, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica…
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2060-2014 Class II | ACL TOP (Base), automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2061-2014 Class II | ACL TOP 700, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2062-2014 Class II | ACL TOP CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2063-2014 Class II | ACL TOP 700 LAS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2064-2014 Class II | ACL TOP 500 CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2066-2014 Class II | ACL TOP 300 CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |