Date Initiated by Firm | June 26, 2020 |
Date Posted | August 04, 2020 |
Recall Status1 |
Terminated 3 on October 19, 2020 |
Recall Number | Z-2751-2020 |
Recall Event ID |
86039 |
Product Classification |
Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
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Product | 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. |
Code Information |
Catalogue Numbers: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135 |
Recalling Firm/ Manufacturer |
RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom
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For Additional Information Contact | Louise Lynn 44-28-94422413 |
Manufacturer Reason for Recall | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. |
FDA Determined Cause 2 | Unknown/Undetermined by firm |
Action | 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. |
Quantity in Commerce | 2219 kits |
Distribution | Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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