CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400 recalled
Horiba Instruments is recalling Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, distributed in 40 states. The recall was initiated on 30 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0119-2020
- FDA event ID
- 83701
- Recalling firm
- Horiba Instruments, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Oct 2018
- FDA classified
- 10 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Oct 2018 | Recall initiated by company | |
| 10 Oct 2019 | Classified by FDA | +345 days |
| 16 Oct 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
Where it was distributed
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
AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiMontana
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
All Lots; All Software versions
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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