Recall Z-0119-2020 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Horiba Instruments Incorporated
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
| Date | Oct 30, 2018 |
| Status | Terminated |
| 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 recom |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.