Recall record at a glance
| Official record | Z-2752-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | RANDOX LABORATORIES, LTD. |
| Report date | Aug 12, 2020 |
| Recall initiation date | Jun 26, 2020 |
| Location | Crumlin Colorado Antrim, United Kingdom |
Official product description
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Why the product was recalled
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
Distribution information
Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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