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, )
This recall has been terminated (originally issued January 4, 2008).
- Company
- Abbott Laboratories
- Recall Initiated
- July 25, 2007
- Posted
- January 4, 2008
- Terminated
- November 17, 2009
- Recall Number
- Z-0301-2008
- Quantity
- 302 units
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
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.
Lot / Code Info
Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007
Root 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