R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.

Class I - Dangerous

🏥 Medical Devices Recalled: August 24, 2016 R & D Systems Diagnostic Equipment

What Should You Do?

Check if you have this product:
331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: R & D Systems, Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

R&D Systems, Quantikine¿ IVD¿sTfR 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 Codes/Lot Numbers:

331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.

Distribution:

Distributed in: US, CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2887-2016

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