FDA Medical Device Recalls (openFDA)
Horiba Instruments Incorporated: Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
- Recall number
- Z-0119-2020
- Recalling firm
- Horiba Instruments Incorporated
- Product
- Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
- Status
- Terminated
- Initiated
- 2018-10-30
- Posted
- not on file
- Terminated
- 2020-06-16
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- All Lots; All Software versions
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CHI
- Firm FEI
- 2086725
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28