CLASS II Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
Randox Lipase Assay: Lipase Colorimetric Reagent recalled
Randox Laboratories is recalling Randox Lipase Assay: Lipase Colorimetric Reagent, distributed nationwide in the US. The recall was initiated on 26 Jun 2020 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-2751-2020
- FDA event ID
- 86039
- Recalling firm
- Randox Laboratories, Crumlin Colorado Antrim
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2020
- FDA classified
- 4 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Jun 2020 | Recall initiated by company | |
| 4 Aug 2020 | Classified by FDA | +39 days |
| 12 Aug 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Questions about this recall
Is Randox Lipase Assay: Lipase Colorimetric Reagent recalled?
Yes. Randox Laboratories recalled Randox Lipase Assay: Lipase Colorimetric Reagent on 26 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2751-2020.
Why was it recalled?
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Which lots are affected?
Catalogue Numbers: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
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 21 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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