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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmNovember 26, 2003
Date PostedJanuary 06, 2004
Recall Status1 Terminated 3 on February 20, 2004
Recall NumberZ-0298-04
Recall Event ID 27905
510(K)NumberK993068 
Product Classification Fluorometric Method, Cpk Or Isoenzymes - Product Code JHX
ProductVitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
Code Information Lot 611, Exp. 25 June 2004
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14650-0881
For Additional Information ContactSherry L. Phillips
585-453-7328
Manufacturer Reason
for Recall		Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
FDA Determined
Cause 2		Other
ActionCustomers notified via phone and faxed letter on 11/26/03. Customers provided with a modified QC procedure to be used until new shipments can be made.
Quantity in Commerce774 reagent packs
Distribution738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JHX
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