Date Initiated by Firm |
November 10, 2009 |
Date Posted |
March 10, 2010 |
Recall Status1 |
Terminated 3 on December 10, 2010 |
Recall Number |
Z-1043-2010 |
Recall Event ID |
53784 |
510(K)Number |
K822469
|
Product Classification |
Calcium Reagent Set - Product Code CIC
|
Product |
Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2.
The product is used for the quantitative determination of calcium in serum on Hitachi analyzers. |
Code Information |
All lots containing 813401 as part of the lot number. |
Recalling Firm/ Manufacturer |
Pointe Scientific, Inc. 5449 Research Dr Canton MI 48188
|
For Additional Information Contact |
734-487-8300
|
Manufacturer Reason for Recall |
Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
|
FDA Determined Cause 2 |
Process control |
Action |
Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300. |
Quantity in Commerce |
4 sets and 9 L |
Distribution |
Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad). |
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 = CIC and Original Applicant = POINTE SCIENTIFIC, INC.
|