Z-0119-2020Class II

Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631...

Name: Z-0119-2020 Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631...
Creator: Horiba Instruments Incorporated
Published: 2018-10-30
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2018-10-30 / Terminated / root cause: design

FDA source

Horiba Instruments Incorporated began a recall of Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944 on 2018-10-30. FDA classified it as Class II and gives the reason as "Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0119-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-30
Posted: 2019-10-10
Terminated: 2020-06-16
Recalling firm: Horiba Instruments Incorporated
Product: Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).
Root cause tag: design
FDA root cause: Device Design
Action: A "field Safety Notice" was mailed to all consignees on XX/XX/XXXX via XXXX. The field safety notice informed customer of the following: 1. If your lipase result is > 38 U/L (or the reference (normal) value of your laboratory) rerun lipase alone: - If result is still > 38 U/L(or the reference value of your laboratory), report the result as abnormal. - If result is < 38 U/L(or the reference value of your laboratory), report the result as a normal. 2. To avoid rerun, another option is to perform lipase test in batch mode (all lipase tests executed consecutively in a same run). 3. Those recommendations will be added on the reagent notice for lipase test. The last revisions of these documents are available on our Documentation web site. 4. Please share this information with your laboratory staff, and retain this notification as part of your Quality System documentation. 5. Please complete and return the enclosed response form within 10 days, in order for us to verify your understanding of this Field Information. 6. If you have any questions regarding this Product Corrective Action, please contact your local Horiba Medical representative or our Technical Service Department at 888-903-5001, option 3, option 2.
Quantity in commerce: 1539 Chemistry Analyzers
Distribution: US: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY
Product codes and lots: All Lots; All Software versions

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-10

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)