VITROS Chemistry Products Calibrator Kit 2 recall
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products…
Why was VITROS Chemistry Products Calibrator Kit 2 recalled?
Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code 1662659; Lots: 1) 212 and 2) 292; Expiry Dates: 1) 2014-08-31 and 2) 2014-02-28.
- Product
- VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 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, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, France, Italy and Spain.
- Recall date
- March 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)