Recall Z-1708-2015 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jun 4, 2015 (initiated Apr 20, 2015) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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 si |
| Quantity | 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, Netherlands, Portugal, and Slovakia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140859 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT Siemens Healthcare Diagnostics, Inc., Nov 26, 2014 |