Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the qu
FDA device recall Z-2752-2020 · posted 2020-08-04 · Terminated
Recall details
- Recalling firm
- RANDOX LABORATORIES, LTD.
- Reason for recall
- Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
- 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.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- CHI
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
- Date initiated
- 2020-06-26
- Date posted
- 2020-08-04
- Date terminated
- 2020-10-19
- Location
- Crumlin Antrim, Colorado, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.