Z-1219-03

Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)

Name: Z-1219-03 Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
Creator: Diagnostic Products Corp
Published: 2003-07-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-07-31 / Terminated

FDA source

Diagnostic Products Corp began a recall of Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit) on 2003-07-31. The reason FDA records is "Kits had parts in them that did not belong in the kit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1219-03
Status: Terminated
Initiated: 2003-07-31
Posted: 2003-09-11
Terminated: 2003-12-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
Product code: LYR Helicobacter Pylori
Reason for recall: Kits had parts in them that did not belong in the kit.
FDA root cause: Other
Action: Customers have been informed to discard kits with the incorrect adjustors in them by fax delivered on 7/31/2003.
Quantity in commerce: 339
Distribution: US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria
Product codes and lots: Lot 118

Product code LYR

K000463Class IImmulite H. Pylori Igg and Immulite 2000 H. Pylori IggDiagnostic Products Corp. / cleared 2000-06-01

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)