Recall Z-1670-2016 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Mar 7, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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. Customer |
| Quantity | 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, Slo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133067 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT Siemens Healthcare Diagnostics, Inc., Nov 22, 2013 |