VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
FDA Recall Z-1152-2013 · Posted 2013-04-19
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeDLZ
Date Initiated2013-03-14
Date Terminated2015-06-23
Product QuantityDomestic: 11,164 units, Foreign: 594 units
Reason for Recall
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.
Firm Action
On 3/14/13, URGENT PRODUCT CORRECTION NOTIFICATION letters (dated 3/14/13), Questions & Answers, and Response Forms were sent to consignees via FedEx courier or US Postal Service Priority Mail. Consignees were informed of the issue and advised to immediately discontinue using VITROS PHBR Slides. On 3/14/13, distributor letters were sent via US Postal Service Priority Mail to the distributors. They were advised of the issue and instructed to discontinue distributing and discard their remaining inventory of VITROS PHBR Slides. On 3/14/13, foreign affiliates were informed by e-mail of the issue and instructed to notify their consignees of the issue and actions.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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