Recall Z-1968-2015
Tecan US, Inc. · initiated May 29, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.
Codes / lots: Material Number 30063849. Serial numbers 1304002505 1211001152 1404000702 1411000822 1401004105 1205001934 1308000225 1309006882 1208001184 1204007588 1310005809 1402004302 1211001148 1305006435 1201003163 1404003953 1406001800 1403005820 1402003587 1311007574 1312002863 1406000407 1406004487 1408007771 1310007970 1201003165 1110002126 1203007860 1309000153 1408007772 1502004994 1410008825 1407000743 1406004488 1201007987 1206005852 1406008272 1410008826 1412004769 1404006185 1212002553 1403008861 1309000008 1211004372 1403000810 1208009323 1211001150 1201003164 1204006296 1407000079 1203002067 1206003111 1304004516 1309000007 1302004940 1309000154 1403000809 1212005340 1309000155 1410000939 1310003905 1409008197 1202003111 1303004426 1112005380 1303003793 1403005819 1407000077 1301009861 1503001027 1304008256 1303003794 1304002504 1309008394 1309008392 1208001186 1110002128 1503001025 1312005136 1310003908 1402005998 1309000157 1403008862 1406001502 1406008274 1406008275 1110002125 1207004756 1303003789 1205004103 1310000091 1406005776 1410011653 1211011467 1308001821 1501009602 1501001058 1307003628 1210001739 1305002229 1406006675 1211004368 1209006283 1407003406 1311001092…
Reason for recall
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1968-2015
- Initiated
- May 29, 2015
- Posted by FDA
- July 2, 2015
- Terminated
- August 18, 2017
- Product code
- KHO – Fluorometer, For Clinical Use
- Quantity
- 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, WA, WI, including DC
- Recalling firm
- Tecan US, Inc., Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1967-2015 Class II | Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | 05/29/2015Terminated |
| Z-1969-2015 Class II | Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | 05/29/2015Terminated |
| Z-1970-2015 Class II | Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | 05/29/2015Terminated |
| Z-1971-2015 Class II | Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | 05/29/2015Terminated |