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

Class 2 Device Recall

  • 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 see related information
Date Initiated by Firm September 02, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on December 10, 2003
Recall Number Z-0028-04
Recall Event ID 27164
Product Classification unknown device name - Product Code LNN
Product Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
Code Information All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.
Recalling Firm/
Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contact
Manufacturer Reason
for Recall
Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
FDA Determined
Cause 2
Action Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.
Quantity in Commerce 21958
Distribution United States, Canada and Germany

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.