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U.S. Department of Health and Human Services

Class 3 Device Recall RANDOX NEFA

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  Class 3 Device Recall RANDOX NEFA see related information
Date Initiated by Firm September 23, 2019
Create Date November 13, 2019
Recall Status1 Terminated 3 on May 07, 2020
Recall Number Z-0367-2020
Recall Event ID 84007
Product Classification Conversion to ferric hydroxymates (colorimetric), fatty acids - Product Code JLG
Product RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Code Information Catalogue number: FA115 GTIN: 05055273203066 Batch/Lot: 485343 Exp: Mar 2019
Recalling Firm/
Manufacturer		 Randox Laboratories, Limited
Ardmore; 55 The Diamond Road
Crumlin United Kingdom
For Additional Information Contact Cheryl O'Hagan
304-728-2890
Manufacturer Reason
for Recall		 Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On September 23, 2019 the firm distributed Urgent Medical Device Recall letters by e-mail instructing them to: - Discontinue use of and discard any of the product detailed above immediately or return remaining product to Randox Laboratories. - Review results generated with the affected batches in line with the clinical profile of the patient. - Discuss the contents of this notice with your Medical Director. - Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. - Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. On October 8, 2019 the firm distributed an amended Urgent Medical Device Recall. However, these letters were not identified as an Amended or Corrected notice. The notice is also still dated 09/23/2019. This updated notice identified the expiration date for the affected product as 28Mar2021. On October 16, 2019, the firm sent a second amended notice to customers via email.
Quantity in Commerce 212 (19 US; 193 OUS)
Distribution WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW
Total Product Life Cycle TPLC Device Report
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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