Z-1152-04

Array Systems Calibrator 5 Part No. 465250

Name: Z-1152-04 Array Systems Calibrator 5 Part No. 465250
Creator: Beckman Coulter Inc
Published: 2003-12-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-12-17 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Array Systems Calibrator 5 Part No. 465250 on 2003-12-17. The reason FDA records is "The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5". 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-1152-04
Status: Terminated
Initiated: 2003-12-17
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Array Systems Calibrator 5 Part No. 465250
Product code: GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Reason for recall: The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.
Root cause tag: manufacturing process
FDA root cause: Other
Quantity in commerce: 1000
Product codes and lots: Lot M305283

Product code GTQ

K926236Class IBeckman Anti-Streptolysin O KitBeckman Instruments, Inc. / cleared 1993-06-15

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)