Recall Z-0301-2008 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, )
| Date | Jan 4, 2008 (initiated Jul 25, 2007) |
| Status | Terminated |
| Reason | Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter |
| Root cause | Nonconforming Material/Component |
| Action | This Recall was initiated 07/24/07 via a Product Recall letter-Immediate Action Required-instructing users to discontinue use and destroy any units under recall. Replacements may be obtained by contacting the local Customer Support Center at 1-877-4Abbott |
| Quantity | 302 units |
| Distribution | Worldwide Distribution: USA including states of AR, AZ, CA, CT, FL, GA, ID, KY, LA, MD, MI, NC, ND, NV, NY, OH, OK, PA, SC, TX, UT, VA, and W I (4 distributors and 50 consignees)and countries of Australia, Brazil, Chile, Germany, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051215 | CELL-DYN SAPPHIRE SYSTEM Abbott Laboratories, Jul 21, 2005 |