Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with inje
FDA device recall Z-1971-2015 · posted 2015-07-02 · Terminated
Recall details
- Recalling firm
- Tecan US, Inc.
- Reason for recall
- A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
- Action taken
- Tecan sent an Urgent Field Corrective Action letter dated May 29, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Customer Response Form. For questions contact your local Tecan Helpdesk.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KHO
- Quantity affected
- 868 in total
- Distribution
- US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, W
- Date initiated
- 2015-05-29
- Date posted
- 2015-07-02
- Date terminated
- 2017-08-18
- Location
- Morrisville, NC
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