Devices

Device Recall Dimension Vista Thyroid Stimulating Hormone (TSH) Flex

Model / Serial
TSH, radioimmunoassay, thyroid stimulating hormone, RF612, SMN# 10464524 Lot codes: 16277BD 16322BB 17005BB 17023AC 17069AA 17093BB 17122AA 17150AA 17193BA 17215AC 17268AA
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada, Mexico, and Thailand
Product Description
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall Dimension Vista Thyroid Stimulating Hormone (TSH) Flex

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

One device with a similar name

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Device Recall Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

Model / Serial
Device Listing Number # D230089 Lot # 16118BD, 16159BA,16193BC,.16193BD,16208AA,16251BA 16277BD,16322BB,17005BB,17023AC
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa
Product Description
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Manufacturer
Siemens Healthcare Diagnostics, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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