Medical Device Recall: Z-0028-04

FDA Recalls dataset · Firm: Roche Diagnostics Corp. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-09-02 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-04.

Recall Res Number
Z-0028-04
Recalling Firm / Manufacturer
Roche Diagnostics Corp.
FEI Number
1823260
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-09-02
Date Posted
2003-10-15
Date Terminated
2003-12-10
Product Code
LNN
Event Number
27164
Product Quantity
21958
Product Description Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
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.
Action Details 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.
Distribution Pattern United States, Canada and Germany
Code Information / Serial Numbers All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.

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