VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRI
FDA device recall Z-0848-2015 · posted 2014-12-22 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
- Action taken
- Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated November 6, 2014, via FedEx overnight courierand/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all affected customers. The letter identified the product, the problem, and the acton to be taken by the customer. The letter informed the customers of the issue and advise them to discontinue use of the affected lot and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. For additional questions, please contact OCD's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CDT
- Quantity affected
- USA: 380 units, Foreign: 155 units
- Distribution
- Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore
- Date initiated
- 2014-11-06
- Date posted
- 2014-12-22
- Date terminated
- 2017-02-28
- 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 |
|---|---|---|
| KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) (K812029) | Eastman Kodak Company | 1981-08-03 |