VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606
FDA device recall Z-1088-2014 · posted 2014-02-25 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
- Action taken
- Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated October 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Ortho Clinical Diagnostics recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample. Please forward a copy of the notification letter if the products were further distributed. Complete and return the attached Confirmation of Receipt form by October 25, 2013. Customers with questions please call Customer Technical Service at 1-800-421-3311.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 19,368 units total (10,328 for lot 212 and 9,040 for lot 292)
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE
- Date initiated
- 2013-10-17
- Date posted
- 2014-02-25
- Date terminated
- 2018-05-18
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K081411) | Ortho-Clinical Diagnostics, Inc. | 2008-06-30 |
| KODAK EKTACHEM 250 ANALYER (K922072) | Eastman Kodak Company | 1992-07-10 |