Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall Z-0321-2014 · Posted 2013-11-15

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeDIP
Date Initiated2013-06-12
Date Terminated2017-04-11
Product Quantity21,163 units (16,218 units domestically & 4,945 units internationally)

Reason for Recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Firm Action

Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated June 12, 2013, to all affected customers via FedEx regarding Slide Dispense issues with various VITROS Chemistry Product Slides. VITROS ALT, CL-, GGT, LDH, K+, Na+ and TP slides use a different ABP, they are not affected by this issue. OCD provided instructions that may allow their customers to reposition the ABP if a jam occurs. OCD will provide you with a credit for any cartridge where the ABP becomes misaligned within the cartridge body in such a way that you are unable to reposition the ABP successfully to resolve the slide dispense issue. In addition to the Confirmation of Receipt form, OCD also enclosed three (3) copies of a Request for Credit form for you to complete when you require credit for affected cartridges. Complete and return the Confirmation of Receipt by June 21, 2013. If you experience slide dispense condition codes more than once a week, call our Customer Technical Support at 1-800-421-3311. For questions regarding this recall call 585-453-4224.

Root Cause

Equipment maintenance

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc. · 2008-10-23K941142KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOINEastman Kodak Company · 1994-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑