Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PLAC Test ELISA Kit

  • 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 PLAC Test ELISA Kitsee related information
Date Initiated by FirmAugust 20, 2010
Date PostedMarch 21, 2011
Recall Status1 Terminated 3 on March 21, 2011
Recall NumberZ-1737-2011
Recall Event ID 56639
510(K)NumberK062234 
Product Classification Lipoprotein-Associated Phospholipase A2 Immunoassay Test System - Product Code NOE
ProductdiaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
Code Information Lot number 910013, expiration date 05/31/2010
FEI Number 3003643666
Recalling Firm/
Manufacturer		 DiaDexus, Inc
343 Oyster Point Blvd
South San Francisco CA 94080
For Additional Information ContactJohn Buhr
650-246-6481
Manufacturer Reason
for Recall		Product fails stability tests prior to expiration date.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA phone script has been prepared to contact customers. Customers were informed of the affected product and its reason for the recall. If customers didn't use the product after May 11, 2010, the action is considered complete. If the product was used after May 11, 2010, a follow up letter will be sent to the customer and they will be asked to re-test any samples beyond May 11, 2010 with an alternate lot of reagent.
Quantity in Commerce482 units
DistributionWorldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel.
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 = NOE
-
-