Z-1069-2009

Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology...

Name: Z-1069-2009 Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology...
Creator: Abbott Laboratories
Published: 2008-12-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-12-10 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott... on 2008-12-10. The reason FDA records is "Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1069-2009
Status: Terminated
Initiated: 2008-12-10
Posted: 2009-04-23
Terminated: 2010-12-27
Recalling firm: Abbott Medical
Product: Hematology 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.
Product code: GKZ Counter, Differential Cell
Reason for recall: Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall 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 commerce: 30 syringes
Distribution: Worldwide Distribution -- USA, Australia, Canada, and Germany.
Product codes and lots: 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.

Product code GKZ

K051215Class IICell-Dyn Sapphire SystemAbbott Laboratories / cleared 2005-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)