—#136080

Product

Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.

FDA product code: JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K140859
Affected lot / code info: Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2015-04-20
Posted by FDA: 2015-06-04
Terminated: 2016-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136080. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.