—#65478

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, )

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K051215
Affected lot / code info: Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007

Why it was recalled

Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-07-25
Posted by FDA: 2008-01-04
Terminated: 2009-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.