Recall Z-1831-2013 ยท DCF Albumin, Antigen, Antiserum, Control
Wako Life Sciences, Inc.
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic elect
| Date | Jul 30, 2013 (initiated Apr 30, 2013) |
| Status | Terminated |
| Reason | Product fails to meet the accuracy at the low end of the measuring range. |
| Root cause | Material/Component Contamination |
| Action | Wako Life Sciences, Inc. sent an email and issued a Recall Notice letter via FED EX on April 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue the use of these kits, fill out the attached RMA form, and return unused kits using Wako's FedEx account (provided on RMA form). Partially used reagent cartridges should be disposed of according to your local and state requirements. Wako Life Sciences will relplace your existing stock of uTASWako DCP kits with kits from a different log number that has been tes |
| Quantity | 36 cartridges -100 tests per cartridge |
| Distribution | Distribution to CA, GA, MN, NC, UT and the District of Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION Wako Chemicals USA, Inc., Feb 23, 2011 |