Recall Z-3043-2018 ยท CGZ Electrode, Ion-Specific, Chloride
Ortho-Clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
| Date | Jul 11, 2018 |
| Status | Terminated |
| Reason | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride. |
| Root cause | Under Investigation by firm |
| Action | On 7/11/18, Important Product Correction Notification letters were distributed to customers. The letters instructed customers to perform the following actions: VITROS Cl- Slides and VITROS CREA Slides Instructions for Use will be updated to contain the revised information described in this letter; we will notify you upon availability. In the interim, retain a copy of this customer letter for your records. Calibration Diskette and ADD Data Release Version (DRV) 5992 (and above) will support the revised measuring range for VITROS CREA Slides. We anticipate that DRV 5992 will be available begi |
| Quantity | 128196 |
| Distribution | Worldwide Distribution - US Nationwide and in the countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071801 | VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 Ortho-Clinical Diagnostics, Inc., Jul 20, 2007 |