Medical Device Recall: Z-0012-04

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

Recall Action Class: N/A Date Initiated: 2003-05-08 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-04.

Recall Res Number
Z-0012-04
Recalling Firm / Manufacturer
Roche Diagnostics Corp.
FEI Number
1823260
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-05-08
Date Posted
2003-10-15
Date Terminated
2003-12-09
Product Code
N/A
Event Number
26231
Product Quantity
478
Product Description Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
Reason for Recall Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.
Action Details Customers were notified by certified mail on or about May 12, 2003. Operators were given a workaround (assure R1 has the lower number of tests remaining before using the analyzer) until new software is supplied.
Distribution Pattern United States
Code Information / Serial Numbers All units with current software versions (v 06-06 and 07-01).

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