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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

Agency Publication Date: May 5, 2017
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Affected Products

Product: Dimension Troponin 1 (TNI) Flex reagent cartridge

Device Listing Number # D056469 Lot # EB7091, EC7104, EA7125, ED7193, EA7161, EB7173, EC7229, ED7236 EA7250, ED7271, EB7315, EB7342 "

Lot Numbers:
EB7091
Product: Dimension Vista Digoxin (DIGXN) Flex reagent cartridge

Device Listing Number # D098364 Lot # 16103BD, 16195BB, 16230BA, 16259BD, 16320BD, 16363BA

Lot Numbers:
16103BD
Product: Dimension Vista Estradiol (E2) Flex reagent cartridge

Device Listing Number # D121541 Lot # 16148AA, 16190BA, 16201BA, 16228BC, 16256BA, 16277BB 16298AB, 16343BE,17005BC

Lot Numbers:
16148AA
Product: Dimension Vista Ferritin (FERR) Flex reagent cartridge

Device Listing Number # D011479 Lot # 16102BF, 16144BB,16196BD,16201BF,16214BF,16236BA 16252AB,16277BC,16284AB,17012BC,17012BD,17034BA,16112BB 16148BA,16165BE,16195BA,16223AD,16259BC,16285BE,16312BD 16334BE,17004BA,17038BC

Lot Numbers:
16102BF
Product: Dimension Vista Prolactin (PRL) Flex reagent cartridge

Device Listing Number # A836016 Lot # 16112BB, 16148BA,16165BE,16195BA,16223AD,16259BC 16285BE,16312BD,16334BE,17004BA,17038BC

Lot Numbers:
16112BB
Product: Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

Device Listing Number # D230089 Lot # 16118BD, 16159BA,16193BC,.16193BD,16208AA,16251BA 16277BD,16322BB,17005BB,17023AC

Lot Numbers:
16118BD

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76915
Status: Resolved
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Manufactured In: United States
Units Affected: 6 products (70,428 units; 13,143 units; 1,697 units; 29,266 units; 3,443 units; 19, 927.00)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.