Recall Z-0465-2019 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Siemens Healthcare Diagnostics, Inc.
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension clinical chemistry system.
| Date | Sep 7, 2018 |
| Status | Terminated |
| Reason | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction letters dated 9/7/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. |
| Quantity | 18396 |
| Distribution | Worldwide - US Nationwide Distributions The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Per |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952816 | LIPASE FLEX REAGENT CARTRIDGE Dupont Medical Products, Jul 20, 1995 |