Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantita

FDA device recall Z-1708-2015 · posted 2015-06-04 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well.

Action taken

Siemens sent an Urgent Medical Device Recall notice, dated April 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. - Review this letter with your Medical Doctor. - Discontinue use and discard your remaining inventory of the reagent lot listed in Table 1. - Indicate your replacement product needs on the attached Field Correction Effectiveness Check form and fax to (312) 275-7795 within 30 days. Siemens will replace any unused inventory of the affected lot at no charge. We apologize for the inconvenience this situation may cause.. If you have any questions, please contact your Siemens Customer Care Center Technical Solutions at 800-441-9258, or your local Siemens technical support representative.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JLW

Quantity affected

2256

Distribution

Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Neth

Date initiated

2015-04-20

Date posted

2015-06-04

Date terminated

2016-12-13

Location

Newark, DE

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