Recall Z-2887-2016
R & D Systems, Inc. · initiated August 24, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
Codes / lots: 331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.
Reason for recall
R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine IVD Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.
FDA-determined cause: Nonconforming Material/Component
Action taken
Consignees were sent via US mail on 8/24/2016 a R&D systems "Urgent Medical Device Recall" letter dated August 23, 2016. The letter described the problem and the product involved in the recall. Advised consignees to stop using the kits and to discard all unused kits and complete and return the enclosed Acknowledgement and Receipt Form. For questions contact Bio-Technes Technical Service Department at 1-612-379-2956 or techserv@bio-techne.com.
Details
- Recall number
- Z-2887-2016
- Initiated
- August 24, 2016
- Posted by FDA
- September 26, 2016
- Terminated
- July 26, 2017
- Product code
- JNM – Immunochemical, Transferrin
- Quantity
- 725 kits (502 US, 223 OUS)
- Distribution
- US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA. OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.
- Recalling firm
- R & D Systems, Inc., Minneapolis, MN