FDAFDA · Food and drugs·Recall number Z-0296-2014
VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Published November 27, 2013 · Recall initiated: June 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics
- Distributor
- Worldwide Distribution - USA (nationwide) including 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, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.
- Lot
- Multiple lots affected, with expiry dates through 22-Mar-2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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