Z-0131-2015Class II

Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system

Name: Z-0131-2015 Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system
Creator: Abbott Laboratories, Inc
Published: 2014-04-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-04-07 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories, Inc began a recall of Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system on 2014-04-07. FDA classified it as Class II and gives the reason as "Package inserts have incorrect SmartWash parameters for Triglyceride". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0131-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-07
Posted: 2014-10-28
Terminated: 2015-04-01
Recalling firm: Abbott Medical
Product: Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: Package inserts have incorrect SmartWash parameters for Triglyceride.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Firm issued a Product Correction Letter to all Lipase reagent customers who received lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11. The letter identified the affected product and provided an explanation of the problem, as well as, the patient impact and actions to be taken. The Product Correction Letter provided guidance for the laboratory to correctly configure the Architect cSystem's Lipase assay parameters. Customers are to retain a copy of the letter for their lab records, and forward a copy to any laboratories that the product was further distributed to. Questions should be directed to Customer Service at 1-877-4ABBOTT or your local customer service for customers outside of the US.
Quantity in commerce: 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.
Product codes and lots: lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0131-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0131-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-27

Product code CHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)