Z-2139-2008

CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott...

Name: Z-2139-2008 CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott...
Creator: Abbott Laboratories
Published: 2008-04-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-04-11 / Terminated / root cause: software

FDA source

Abbott Laboratories began a recall of CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott Diagnostics Division, Santa Clara, CA For in vitro... on 2008-04-11. The reason FDA records is "Table in LIS Specification depicting the association between Record ID and Numerical Result Label is incorrect. If a record ID is used to configure the system for mapping, results will come out nonsensical". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2139-2008
Status: Terminated
Initiated: 2008-04-11
Posted: 2008-08-21
Terminated: 2010-03-12
Recalling firm: Abbott Medical
Product: CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott Diagnostics Division, Santa Clara, CA For in vitro diagnostic use in counting and characterizing blood cells.
Product code: GKZ Counter, Differential Cell
Reason for recall: Table in LIS Specification depicting the association between Record ID and Numerical Result Label is incorrect. If a record ID is used to configure the system for mapping, results will come out nonsensical.
Root cause tag: software
FDA root cause: Software change control
Action: Recall initiated on April 11, 2008. A Product Correction letter and customer reply form were sent to all currently active CELL-DYN Sapphire Customers. The letter requests that users be certain that the transmission of test results receipt by the host interface is mapped according to the Numerical Result Label, when configuring their CELL-DYN Sapphire Hematology Analyzer for results transmission to a Clinical Laboratory Information System or Middleware. Affected product was distributed to a total of 4 distributors. However, notification was made to all 154 customers that received the CELL-DYNE Sapphire product. If the customer or the health care providers that they serve have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT.
Quantity in commerce: 15 copies of the specification were sent worldwide
Distribution: Nationwide Distribution.
Product codes and lots: Revision B.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)