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 ARCHITECT Free T4 Calibrator 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 ARCHITECT Free T4 Calibrator Kitsee related information
Date Initiated by FirmDecember 15, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 22, 2004
Recall NumberZ-0353-04
Recall Event ID 27977
510(K)NumberK983417 
Product Classification unknown device name - Product Code CEC--
ProductARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
Code Information lots 94493M300 and 94493M301
FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information ContactAbbott Customer Service
877-422-2688
Manufacturer Reason
for Recall		The calibrator lots may yield Free T4 values that are depressed.
FDA Determined
Cause 2		Other
ActionArchitect Free T4 Calibrator kits were recalled by letter dated 12/15/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the kits, and were requested to discontinue use and destroy the affected lots of product.
Quantity in Commerce1,364 kits
DistributionNationwide and internationally to Abbott subsidiaries in Brazil, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Colombia, New Zealand, Venezuela and Taiwan.
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 = CEC--
-
-