Z-2887-2016Class II

R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin...

Name: Z-2887-2016 R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin...
Creator: R & D Systems, Inc.
Published: 2016-08-24
License: https://open.fda.gov/license/

R & D Systems, Inc. / initiated 2016-08-24 / Terminated / root cause: manufacturing process

FDA source

R & D Systems, Inc. began a recall of R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and... on 2016-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2887-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Posted: 2016-09-26
Terminated: 2017-07-26
Recalling firm: R & D Systems, Inc.
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.
Product code: JNM Immunochemical, Transferrin
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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].
Quantity in commerce: 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.
Product codes and lots: 331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2887-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2887-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-26

Product code JNM

K970718Class IIQuantikine IVD Stfr Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. / cleared 1997-05-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)