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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

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 Class 2 Device Recall Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridgesee related information
Date Initiated by FirmMarch 21, 2017
Date PostedMay 05, 2017
Recall Status1 Terminated 3 on August 03, 2018
Recall NumberZ-2611-2017
Recall Event ID 76915
510(K)NumberK140859 
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
ProductDimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Code Information Device Listing Number # D230089 Lot # 16118BD, 16159BA,16193BC,.16193BD,16208AA,16251BA 16277BD,16322BB,17005BB,17023AC 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionSiemens mailed an Urgent Medical Device Correction Letter to affected customers on 03/29/2017 to inform them of the issue. The notice explained the reason for the field action, Risk to Health and actions to be taken by the customer.
Quantity in Commerce19, 927.00
DistributionProduct 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JLW
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