Date Initiated by Firm | December 12, 2014 |
Date Posted | September 16, 2015 |
Recall Status1 |
Terminated 3 on October 29, 2015 |
Recall Number | Z-2773-2015 |
Recall Event ID |
71974 |
510(K)Number | K830556 |
Product Classification |
Alkaline picrate, colorimetry, creatinine - Product Code CGX
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Product | Pointe Scientific Creatinine Reagent
Catalog number C7539-150
in vitro diagnostic
C7539-150 kit includes one R1 and one R2 bottle.
R1: HDPE plastic bottle. 120 ml fill.
R2: HDPE plastic bottle. 90 ml fill. |
Code Information |
C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03 |
Recalling Firm/ Manufacturer |
Pointe Scientific, Inc. 5449 Research Dr Canton MI 48188-2261
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For Additional Information Contact | Customer Support 734-483-1592 |
Manufacturer Reason for Recall | Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications. |
FDA Determined Cause 2 | Process control |
Action | On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Any questions concerning the corrective action may be directed to Pointe Scientifics Technical Service Department at 1-800-757-5313. |
Quantity in Commerce | 93 kits |
Distribution | Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines. |
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 = CGX
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