Date Initiated by Firm | February 13, 2019 |
Create Date | March 26, 2019 |
Recall Status1 |
Terminated 3 on April 14, 2020 |
Recall Number | Z-1057-2019 |
Recall Event ID |
82195 |
510(K)Number | K093384 |
Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
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Product | Randox Blood Gas Control Level 2 -Model BG5002.
In-vitro Diagnostic Quality control of Blood Gas analysis
This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2. |
Code Information |
Lot Code: 184BG GTIN: 05055273227116 |
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
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Manufacturer Reason for Recall | An error in the assignment of the control range pH in Blood Gas Control |
FDA Determined Cause 2 | Process control |
Action | The firm, Randox Laboratories Ltd, sent an "Urgent Medical Device Correction
" letter dated 2/13/2019 to its customer on 2/13/2019 via email. The letter describes the product, problem and actions to be taken. The customer was instructed todo the following:
" Please replace the amended value sheet within the kit of any remaining stock.
" Discuss the contents of this notice with your Medical Director.
" Randox Laboratories Ltd is not recommending a review of previous results as any issue would be observed at the time of use.
" Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
" Complete and return the response form 12187-QA to technical.services@randox.com within five working days.
If you have any questions or concerns, please contact Randox Technical Services by email at technical.services@randox.com, or telephone +44 (0)28 9442 2413 or Email: vigilance@randox.com. |
Quantity in Commerce | 1 kit |
Distribution | US Distribution to state of: 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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510(K) Database | 510(K)s with Product Code = JJY
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