ACL TOP 300 and ACL TOP 300 CTS recall
ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro…
Why was ACL TOP 300 and ACL TOP 300 CTS recalled?
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro…
- Recalling firm
- Instrumentation Laboratory Co.
- Quantity
- 662
- 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, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.
- Recall date
- September 25, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)