uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osak
FDA device recall Z-1831-2013 · posted 2013-07-30 · Terminated
Recall details
- Recalling firm
- Wako Life Sciences, Inc.
- Reason for recall
- Product fails to meet the accuracy at the low end of the measuring range.
- Action taken
- 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 tested and has shown to not be affected. If you have any questions regarding the Recall, please submit your inquiries to liver@wakousa.com or call 443-535-0702.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- DCF
- Quantity affected
- 36 cartridges -100 tests per cartridge
- Distribution
- Distribution to CA, GA, MN, NC, UT and the District of Columbia.
- Date initiated
- 2013-04-30
- Date posted
- 2013-07-30
- Date terminated
- 2013-08-19
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION (K100464) | Wako Chemicals USA, Inc. | 2011-02-23 |