—#135838

Product

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.

FDA product code: CEE — Radioimmunoassay, Thyroxine-Binding Globulin
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K950072
Affected lot / code info: LOT 0257, SMN 10381643

Why it was recalled

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 (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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 forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions call (914) 631-8000.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.

Timeline

Recall initiated: 2015-04-09
Posted by FDA: 2015-05-19
Terminated: 2017-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135838. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.