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U.S. Department of Health and Human Services

Class 2 Device Recall Calcium test system

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  Class 2 Device Recall Calcium test system see related information
Date Initiated by Firm October 11, 2010
Date Posted March 25, 2011
Recall Status1 Terminated 3 on September 13, 2011
Recall Number Z-1824-2011
Recall Event ID 57455
510(K)Number K963292  
Product Classification Cresolphthalein complexone, calcium - Product Code CIC
Product Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation, Indianapolis, IN.

For the in vitro quantitative determination of calcium in serum, plasma and urine.
Code Information 62602201
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis IN 46256-1025
For Additional Information Contact Betsy Cox
317-576-2000 Ext. 249
Manufacturer Reason
for Recall		 Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of precipitate in the R2 of the affected calcium reagent lots. The precipitate observed was classified as o-cresolphthalein complexone (o-CPC), a reactive component of the calcium R2. The root cau
FDA Determined
Cause 2		 Other
Action The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference. The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.
Quantity in Commerce 14,528 units
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report
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 = CIC and Original Applicant = ROCHE DIAGNOSTIC SYSTEMS, INC.
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