Recall Z-2752-2020
Randox Laboratories, Ltd. · initiated June 26, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalogue Numbers: LI011/004/UL, LI011/000/UL Lot #: 1048LI, 1050LI
Reason for recall
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
Randox sent an urgent medical device correction notification dated June 22, 2020 explaining the current failure with select lots of Lipase Colorimetric products. The firm advised customers to scrap all effected product, keep proof of destruction, review replacements needs, review results of patients generated using affected batches and return the firm's response card.
Details
- Recall number
- Z-2752-2020
- Initiated
- June 26, 2020
- Posted by FDA
- August 4, 2020
- Terminated
- October 19, 2020
- Product code
- CHI – Lipase-Esterase, Enzymatic, Photometric, Lipase
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
- Recalling firm
- Randox Laboratories, Ltd., Crumlin Antrim, Colorado
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2751-2020 Class II | Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system…Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase… | 06/26/2020Terminated |
| Z-2753-2020 Class II | Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test…Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase… | 06/26/2020Terminated |