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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (P
Recalled May 1, 2013 · FDA recall Z-1152-2013 · Ortho-Clinical Diagnostics
Hazard
Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids. · FDA Class II
Units
Domestic: 11,164 units, Foreign: 594 units
Sold at
Worldwide Distribution-USA (nationwide) and 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.
Description
Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
Product
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →