Recall Z-1970-2015
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 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.
Codes / lots: Material Number 30050303. Serial numbers 1501008516 1106001345 1301002808 1302009129 1110007010 1308006467 1211001078 1204007050 1401006368 1409008005 1412005114 1009003261 1210009373 1104000436 1009006192 1305001434 1310010334 1402000382 1410007778 1208006946 1007000392 1305010270 1405002521 1304005224 1401004534 1405006969 1111000103 1210007330 1502007386 1401007346 1412005118 1203003218 1007005229 1301007222 1006004109 1307006588 1311000218 1112005413 1305008099 1208009225 1212000034 1301009476 1311003918 1206001011 1212000035 1211009784 1403007992 1207007478 1201006124 1408006474 1408006475 1304000220 1401006366 1301009472 1401009553 1305004119 1108003415 1311000214 1309003843 1408002770 1403004653 1009006194 1306007913 1111007888 1009004379 1302001636 1105001261 1106002181 1208005752 1307006587 1112005785 1212004214 1402003539 1307001047 1410002321 1401009545 1409005578 1407000606 1112004304 1011004727 1011004728 1411004683 1407000614 1009004894 1009004895 1412005121 1105005792 1208002653 1101006577 1310006280 1202000758 1210005464 1405002507 1212003129 1404001420 1406007259 1411004208 1008006784 1301009464 1309003841 1405000435 1402006217 1201002015 1502003021 1211001056…
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-1970-2015
- 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-1968-2015 Class II | Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO 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-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 |