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.
Reported: May 25, 2016 Initiated: March 7, 2016 #Z-1670-2016
Product Description
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.
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 7,433 units (4,228 for lot 348297 and 3,199 for lot # 359932)
- Distribution
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 7,433 units (4,228 for lot 348297 and 3,199 for lot # 359932).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2016. Severity: Moderate. Recall number: Z-1670-2016.
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