VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall Z-1615-2013 · Posted 2013-06-27
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeDCK
Date Initiated2013-05-09
Date Terminated2015-06-12
Product QuantityDomestic: 4,257; Foreign: 923
Reason for Recall
While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.
Firm Action
Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 9, 2013 via FedEx or US Priority Mail to all US customers. Foreign Affiliates were notified by e-mail on May 9, 2013 informing them of the issue. Distributors were instructed to notify their customers of the recall. Customers were instructed to discontinue use, discard the affected product, comp[lete and return the attached Confirmation of Recipt Form, and post this notification by each VITROS System. For questions call Customer Service Center at 1-800-828-6316.
Root Cause
Employee error
Distribution Pattern
Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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