Recall Z-0304-2014
Ortho-Clinical Diagnostics · initiated June 12, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Codes / lots: Multiple lots affected, with expiry dates through 22-Mar-2015
Reason for recall
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
FDA-determined cause: Equipment maintenance
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.
Details
- Recall number
- Z-0304-2014
- Initiated
- June 12, 2013
- Posted by FDA
- November 15, 2013
- Terminated
- April 11, 2017
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Quantity
- 28,855 units (12,472 units domestically & 16,383 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, 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…
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0292-2014 Class II | VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0293-2014 Class II | VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0294-2014 Class II | VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0295-2014 Class II | VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0296-2014 Class II | VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0297-2014 Class II | VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0298-2014 Class II | VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0299-2014 Class II | VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0300-2014 Class II | VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0301-2014 Class II | VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0302-2014 Class II | VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0303-2014 Class II | VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0305-2014 Class II | VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0306-2014 Class II | VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0307-2014 Class II | VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0308-2014 Class II | VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0309-2014 Class II | VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0310-2014 Class II | VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0311-2014 Class II | VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0312-2014 Class II | VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0313-2014 Class II | VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0314-2014 Class II | VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0315-2014 Class II | VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0316-2014 Class II | VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0317-2014 Class II | VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0318-2014 Class II | VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0319-2014 Class II | VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0320-2014 Class II | VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0321-2014 Class II | VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |
| Z-0322-2014 Class II | VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | 06/12/2013Terminated |