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U.S. Department of Health and Human Services

Class 2 Device Recall Modular P

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  Class 2 Device Recall Modular P see related information
Date Initiated by Firm May 08, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on December 09, 2003
Recall Number Z-0012-04
Recall Event ID 26231
510(K)Number K953239  
Product Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
Code Information All units with current software versions (v 06-06 and 07-01).
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contact
800-428-2336
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 478
Distribution United States
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) Database 510(K)s with Product Code = and Original Applicant = BOEHRINGER MANNHEIM CORP.
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