| Date Initiated by Firm | August 08, 2017 |
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| Create Date | March 09, 2018 |
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| Recall Status1 |
Terminated 3 on September 05, 2018 |
| Recall Number | Z-0937-2018 |
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| Recall Event ID |
79035 |
| 510(K)Number | K110534 |
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| Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
|
| Product | Liquid Cardiac Control CQ5053 |
|---|
| Code Information |
Lot 4069CK |
| FEI Number |
1000361607
|
Recalling Firm/
Manufacturer |
Randox Laboratories, Limited
Ardmore 55 The Diamond Road
Crumlin United Kingdom
|
Manufacturer Reason
for Recall | Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field. |
|---|
FDA Determined
Cause 2 | Unknown/Undetermined by firm |
|---|
| Action | A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction. |
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| Quantity in Commerce | 450 kits |
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| Distribution | Nationally |
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| 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.
|
| 510(K) Database | 510(K)s with Product Code = JJY
|
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