• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Alkaline Phosphatase Reagent Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Liquid Alkaline Phosphatase Reagent Setsee related information
Date Initiated by FirmFebruary 07, 2008
Date PostedMarch 27, 2008
Recall Status1 Terminated 3 on June 12, 2009
Recall NumberZ-1360-2008
Recall Event ID 46783
510(K)NumberK973588 
Product Classification Liquid Alkaline Phosphatase Reagent Set - Product Code CJE
ProductLiquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc
Code Information All Lots beginning with 727801; exp. 4/09.
Recalling Firm/
Manufacturer
Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
800-757-5313
Manufacturer Reason
for Recall
May be contaminated with microorganisms.
FDA Determined
Cause 2
Other
ActionConsignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.
Quantity in Commerce6
DistributionWorldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CJE
-
-