| Date Initiated by Firm | August 11, 2017 |
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| Create Date | March 12, 2018 |
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| Recall Status1 |
Terminated 3 on March 29, 2019 |
| Recall Number | Z-0969-2018 |
|---|
| Recall Event ID |
79076 |
| 510(K)Number | K140522 |
|---|
| Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
|
| Product | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) |
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| Code Information |
Catalog numbers: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC) |
Recalling Firm/
Manufacturer |
Randox Laboratories
515 Industrial Blvd
Kearneysville WV 25430-2778
|
Manufacturer Reason
for Recall | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. |
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FDA Determined
Cause 2 | Device Design |
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| Action | On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to technical.services@randox.com |
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| Quantity in Commerce | 117 Kits |
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| Distribution | Distribution US nationwide. |
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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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