CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Lipase, Catalog number: LI3837; Gtin: 05055273204230 and Catalog recalled
Randox Laboratories is recalling Lipase, Catalog number: LI3837; Gtin: 05055273204230 and Catalog, distributed nationwide in the US. The recall was initiated on 2 Mar 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-1631-2018
- FDA event ID
- 79767
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2018
- FDA classified
- 4 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Mar 2018 | Recall initiated by company | |
| 4 May 2018 | Classified by FDA | +63 days |
| 16 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
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
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Where it was distributed
US Nationwide Distribution in the states of West Virginia and Puerto Rico
Questions about this recall
Why was it recalled?
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
Which lots are affected?
Lot numbers: 428000, 404175, and 404245
Where was it sold?
US Nationwide Distribution in the states of West Virginia and Puerto Rico
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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