—#167890

Product

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.

FDA product code: CHI — Lipase-Esterase, Enzymatic, Photometric, Lipase
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K952816
Affected lot / code info: Lot Numbers: GD9002, GA9003, GB9032, GA9038

Why it was recalled

There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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, Peru, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahamas, Belgium, Czech Republic, Denmark, , France, , Italy, Netherland, Norway , Portugal, Kuwait, Slovenia, Spain, Switzerland, United Kingdom, Qatar, Republic of Korea, Saudi Arabia, Slovakia, Algeria, Bahrain, Bulgaria, Egypt, , Hungary, Latvia, Lebanon, Lithuania, Macedonia, Nepal, Poland, Romania, Russia Fed, Serbia, Turkey, U.A.E, United Kingdom.

Timeline

Recall initiated: 2018-09-07
Terminated: 2020-11-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.