Recall Z-1830-2013
Tosoh Smd Inc · initiated May 15, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
Codes / lots: The following lots numbers are affected by this recall: 060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012.
Reason for recall
Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.
FDA-determined cause: Nonconforming Material/Component
Action taken
Tosoh Bioscience sent an Urgent Recall Notification letter dated May 15, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to respond on the amount of product that was destroyed by completing the attached form and faxing it to 614-317-1941. Customers with questions were instructed to call Tosoh Technical Support at 1-800-248-6764. For questions regarding this recall call 614-317-1909.
Details
- Recall number
- Z-1830-2013
- Initiated
- May 15, 2013
- Posted by FDA
- July 30, 2013
- Terminated
- November 27, 2013
- Product code
- KHO – Fluorometer, For Clinical Use
- Quantity
- 11,309 bags
- Distribution
- Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.
- Recalling firm
- Tosoh Smd Inc, Grove City, OH