IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum,

FDA device recall Z-1629-2015 · posted 2015-05-19 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

CEE

Quantity affected

155 kits

Distribution

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

Date initiated

2015-04-09

Date posted

2015-05-19

Date terminated

2017-03-22

Location

Tarrytown, NY

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