—#39550

Product

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 product code: KLT — Enzyme Immunoassay, Carbamazepine
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K980283
Affected lot / code info: Generations 18, 19, 20, 21, and 23

Why it was recalled

Falsely elevated Carbamazepine results.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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)

Timeline

Recall initiated: 2005-05-26
Posted by FDA: 2005-07-16
Terminated: 2006-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39550. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.