Recall Z-1117-2012 ยท DLZ Enzyme Immunoassay, Phenobarbital
Ortho-Clinical Diagnostics
VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. For in vitro diagnostic use only. VITROS Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma us
| Date | Feb 28, 2012 (initiated Jun 23, 2011) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS Chemistry Products PHBR Slides (Phenobarbital) from Coating 0053. |
| Root cause | Nonconforming Material/Component |
| Action | Ortho Clinical Diagnostics sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated June 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using and discard all remaining lots of the affected product. A Confirmation of Receipt Form was attached so customers may complete and return to the firm. The firm recommends that customers consult with their Laboratory Medical Director and requesting physician to resolve any concerns they may have regarding previously reported resu |
| Quantity | Domestic - 2345 sale units, Foreign - 632 sales units |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, 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 |