Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or…

Recall date

May 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2273-2016

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Worldwide Distribution - US Nationwide in the countries of Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland and Venezuela.

Why it was recalled

Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).