Recall Z-1152-2013 ยท DLZ Enzyme Immunoassay, Phenobarbital
Ortho-Clinical Diagnostics
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
| Date | Apr 19, 2013 (initiated Mar 14, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Unknown/Undetermined by 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 iss |
| Quantity | 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 of Panama, Singapore, Spain, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984288 | VITROS CHEMISTRY PRODUCTS PHBR SLIDES Ortho-Clinical Diagnostics, Inc., Jan 26, 1999 |