Recall Z-0301-2008
Abbott Laboratories · initiated July 25, 2007
Product
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, )
Codes / lots: Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007
Reason for recall
Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
FDA-determined cause: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-0301-2008
- Initiated
- July 25, 2007
- Posted by FDA
- January 4, 2008
- Terminated
- November 17, 2009
- Product code
- GKZ – Counter, Differential Cell
- 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.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA