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Terminated

Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.

FDA Recall Z-1016-05 · Posted 2005-07-16

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeKLT
Date Initiated2005-05-26
Date Terminated2006-06-12
Product Quantity5,846 boxes

Reason for Recall

Falsely elevated Carbamazepine results.

Firm Action

Letters dated 5/26/05 with instructions to discontinue use and discard slides. Customers also instructed to review previous results with Laboratory Medical Director to determine need for further consultation with health care provider.

Root Cause

Other

Distribution Pattern

423 U.S. consignees nationwide, and 22 OCD/J&J foreign affiliates (Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980283VITROS CHEMISTRY PRODUCTS CRBM SLIDESJohnson & Johnson Clinical Diagnostics, Inc. · 1998-02-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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