Lipase Reagent recall
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Why was Lipase Reagent recalled?
Package inserts have incorrect SmartWash parameters for Triglyceride.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11.
- Product
- Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
- Recalling firm
- Abbott Laboratories, Inc
- Quantity
- 11916 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.
- Recall date
- November 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)