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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 26, 2003
Date Posted January 06, 2004
Recall Status1 Terminated 3 on February 20, 2004
Recall Number Z-0298-04
Recall Event ID 27905
510(K)Number K993068  
Product Classification Fluorometric Method, Cpk Or Isoenzymes - Product Code JHX
Product Vitros 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/
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14650-0881
For Additional Information Contact Sherry L. Phillips
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
Action Customers 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 Commerce 774 reagent packs
Distribution 738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.
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 = JHX and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS