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U.S. Department of Health and Human Services

Class 2 Device Recall Hemoglobin Reagent Syringe (CELLDYN Sapphire)

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 Class 2 Device Recall Hemoglobin Reagent Syringe (CELLDYN Sapphire)see related information
Date Initiated by FirmDecember 10, 2008
Date PostedApril 23, 2009
Recall Status1 Terminated 3 on December 27, 2010
Recall NumberZ-1069-2009
Recall Event ID 50530
510(K)NumberK051215 
Product Classification Differential Cell Counter - Product Code GKZ
ProductHematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA.
Code Information Barcode numbers Starting with SYR-S12E-, and ending with 0066, 0074, 0078, 0079, 0097, 0100, 0244, 0130, 0134, 0144, 0145, 0146, 0147, 0245, 0148, 0153, 0211, 0213, 0216, 0217, 0247, 0218, 0222, 0224, 0225, 0232, 0234, 0248, 0235, 0236, 0237, 0239, 0240, and 0243.
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact
408-982-4800
Manufacturer Reason
for Recall		Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
FDA Determined
Cause 2		Process control
ActionRecall initiated on December 10, 2008. A product recall letter and reply form were cent to CELL-DYN Sapphire customers who received syringes between September 16, 2008 and October 28, 2008 to US customers, and to November 5, 2008 for Outside-of-US customers.
Quantity in Commerce30 syringes
DistributionWorldwide Distribution -- USA, Australia, Canada, and Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GKZ
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