Recall Z-2273-2016 ยท CJY Azo Dye, Calcium
Ortho-Clinical Diagnostics
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease
| Date | May 18, 2016 |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue. |
| Root cause | Nonconforming Material/Component |
| Action | Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION letter dated May 18, 2016 to affected customers. . The letter identified the affected product, problem and actions to be taken. The letter instructed to discontinue use of the affected lot(s) and discard all remaining inventory. Customers were asked to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311. |
| Quantity | US: 27,625 sales units; Foreign: 4757 sales units |
| Distribution | Worldwide Distribution - US Nationwide in the countries of Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072440 | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) Ortho-Clinical Diagnostics, Inc., Sep 20, 2007 |