AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer
FDA device recall Z-1830-2013 · posted 2013-07-30 · Terminated
Recall details
- Recalling firm
- Tosoh Smd Inc
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KHO
- Quantity affected
- 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, V
- Date initiated
- 2013-05-15
- Date posted
- 2013-07-30
- Date terminated
- 2013-11-27
- Location
- Grove City, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K971103) | Tosoh Medics, Inc. | 1997-06-27 |