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Terminated

ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.

FDA Recall Z-1670-2016 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCDT
Date Initiated2016-03-07
Date Terminated2017-12-01
Product Quantity7,433 units (4,228 for lot 348297 and 3,199 for lot # 359932)

Reason for Recall

Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.

Firm Action

Siemens mailed an Urgent Field Safety Notice, dated March 2016, to customers confirming the ADVIA Triglyceride concentrated reagent (TRIG_c) does not meet Instructions for Use (IFU) linearity claim at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932. Siemens asked customers to discontinue use of and discard kits from the two referenced lots, complete and return the Field Correction Effectiveness Check attached to the letter within 30 days. Customers were to review their inventory to determine their laboratory 's replacement needs. Customers are asked to retain the letter for their records and forward a copy to anyone that received the product. Customers may contact Siemens Customers Service or their local technical support.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great Britain, Italy, Latvia, Netherland, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc. · 2013-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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