| | Class 2 Device Recall Genesys Analytical Column |  |
| Date Initiated by Firm | November 01, 2018 |
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| Create Date | December 18, 2018 |
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| Recall Status1 |
Terminated 3 on June 21, 2022 |
| Recall Number | Z-0621-2019 |
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| Recall Event ID |
81488 |
| Product Classification |
Abnormal hemoglobin quantitation - Product Code GKA
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| Product | Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. |
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| Code Information |
all serial numbers |
| FEI Number |
1318354
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Recalling Firm/
Manufacturer |
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
2823 Girts Rd
Jamestown NY 14701-9666
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| For Additional Information Contact |
716-483-3851 |
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Manufacturer Reason
for Recall | lack of 510K |
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FDA Determined
Cause 2 | No Marketing Application |
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| Action | The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items. |
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| Quantity in Commerce | 372 units |
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| Distribution | IL, WV, NJ, AZ, MD, UT |
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| 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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