VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitative

FDA device recall Z-0308-2014 · posted 2013-11-15 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

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

Action taken

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

Status

Terminated

Product code

JFY

Quantity affected

364,752 units (148,285 units domestically & 216,467 units internationally)

Distribution

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,

Date initiated

2013-06-12

Date posted

2013-11-15

Date terminated

2017-04-11

Location

Rochester, NY

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