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.
FDA Recall Z-2887-2016 · Posted 2016-09-26
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Recalling FirmR & D Systems, Inc.
Recall StatusTerminated
Product CodeJNM
Date Initiated2016-08-24
Date Terminated2017-07-26
Product Quantity725 kits (502 US, 223 OUS)
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.
Firm Action
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 [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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