Recall Z-0319-2014 ยท DLZ Enzyme Immunoassay, Phenobarbital
Ortho-Clinical Diagnostics
VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
| Date | Nov 15, 2013 (initiated Jun 12, 2013) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| Root cause | Equipment maintenance |
| 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 success |
| Quantity | 6,606 units (5,071 units domestically & 1,535 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 Aust |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984288 | VITROS CHEMISTRY PRODUCTS PHBR SLIDES Ortho-Clinical Diagnostics, Inc., Jan 26, 1999 |