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

Class 2 Device Recall MULTIGENT Acetaminophen for use with Architect/Aeroset

  • 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 MULTIGENT Acetaminophen for use with Architect/Aeroset see related information
Date Initiated by Firm May 29, 2012
Date Posted June 27, 2012
Recall Status1 Terminated 3 on November 14, 2012
Recall Number Z-1902-2012
Recall Event ID 62017
510(K)Number k042330  
Product Classification Colorimetry, acetaminophen - Product Code LDP
Product MULTIGENT Acetaminophen for use with Architect/Aeroset
Cat. No. 2K99-20.

Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Code Information Lot 41928UQ11 {exp 2013-01 -31 ) 
Recalling Firm/
Manufacturer
Sekisui Diagnostics Llc
31 New York Ave
Framingham MA 01701-8860
For Additional Information Contact
508-661-1154
Manufacturer Reason
for Recall
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
FDA Determined
Cause 2
Storage
Action Sekisui Diagnostics Llc sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop using the affected product and to destroy any remaining inventory. A Confirmation of Notification Form was attached for customers to complete and return via fax to 902-628-6504. Contact the firm at 902-628-0984 for questions regarding this notice.
Quantity in Commerce 1600 kits
Distribution Illinois
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 = LDP and Original Applicant = DIAGNOSTIC CHEMICALS LTD.
-
-