VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-
FDA device recall Z-1117-2012 · posted 2012-02-28 · 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 control fluid values when using various lots of VITROS Chemistry Products PHBR Slides (Phenobarbital) from Coating 0053.
- Action taken
- 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 results. Contact Customer Technical Services at 1-800-421-3311 for questions regarding this notification.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DLZ
- Quantity affected
- 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, Pa
- Date initiated
- 2011-06-23
- Date posted
- 2012-02-28
- Date terminated
- 2016-05-10
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS PHBR SLIDES (K984288) | Ortho-Clinical Diagnostics, Inc. | 1999-01-26 |