Class 2 Device Recall

• Date Initiated by Firm: September 02, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated 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.
• FEI Number: 1823260
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Road; Indianapolis IN 46250-0457
• For Additional Information Contact: 800-428-2336
• 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: Other
• 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.