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, ) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, )
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Package Dates (printed on syringe label), 08 May 2007 to 25 June 2007
Products Sold
Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007
Abbott Laboratories is recalling Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abb due to Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CT, FL, GA, ID, KY, LA, MD, MI, NV, NY, NC, ND, OH, OK, PA, SC, TX, UT, VA
Page updated: Jan 10, 2026