Recall Z-1629-2015 ยท CEE Radioimmunoassay, Thyroxine-Binding Globulin
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
| Date | May 19, 2015 (initiated Apr 9, 2015) |
| Status | Terminated |
| Reason | IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values. |
| Root cause | Unknown/Undetermined by firm |
| Action | Siemens sent an Urgent Field Safety 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. Actions to be Taken by the Customer Discontinue use and discard kit lot listed in Table 1. Review your inventory of these products to determine your laboratory's replacement needs. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days. Please retain this letter with your laboratory records, and f |
| Quantity | 155 kits |
| Distribution | Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950072 | IMMULITE(R) TBG Diagnostic Products Corp., Apr 3, 1995 |