Date Initiated by Firm | November 19, 2018 |
Create Date | December 21, 2018 |
Recall Status1 |
Terminated 3 on April 23, 2020 |
Recall Number | Z-0660-2019 |
Recall Event ID |
81664 |
510(K)Number | K031608 |
Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
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Product | SP CAL (LIQ), REF IT2692
This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution. |
Code Information |
05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019 |
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
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Manufacturer Reason for Recall | Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On November 19, 2018, Randox Laboratories Ltd. issued "Urgent Medical Device Correction" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers.
Customers were advised to take the following action:
- Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided.
- Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient.
- Retain a copy of the letter with laboratory records and forward a copy of the letter to those who may have received this product.
- Return the completed response form via email to technical.services@randox.com.
If you have any questions, contact RA Specialist by email at maria.kelly@randox.com. |
Quantity in Commerce | 250 kits (32 kits US / 218 kits OUS) |
Distribution | US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland. |
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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510(K) Database | 510(K)s with Product Code = JIX
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