VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR

FDA device recall Z-1152-2013 · posted 2013-04-19 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

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.

Action taken

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

Status

Terminated

Product code

DLZ

Quantity affected

Domestic: 11,164 units, Foreign: 594 units

Distribution

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

Date initiated

2013-03-14

Date posted

2013-04-19

Date terminated

2015-06-23

Location

Rochester, NY

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