Recall Z-0092-2017 ยท KNK Acid, Uric, Uricase (Colorimetric)
Ortho-Clinical Diagnostics
VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
| Date | Aug 11, 2016 |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. |
| Root cause | Under Investigation by firm |
| Action | Ortho-Clinical Diagnostics sent an URGENT PRODUCT CORRECTION Letter (Ref. CL2016-152) dated August 11, 2016 via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all customers who could order and use affected product to inform them that new interferant were identified for GLU, LAC, TRIG and URIC Slides which may cause biased results. Foreign affiliates were informed by e-mail on August 11, 2016, of the issue and instructed to notify their consignees of the issue. For questions, please contact our Ortho CareTM Technical So |
| Quantity | US: 18,749 sales units; Foreign: 94,928 sales units |
| Distribution | Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932728 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) Eastman Kodak Company, Apr 25, 1994 |