Z-1031-03

Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO...

Name: Z-1031-03 Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO...
Creator: Zeus Scientific Inc
Published: 2001-11-09
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2001-11-09 / Terminated / root cause: manufacturing process

FDA source

Zeus Scientific Inc began a recall of Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ on 2001-11-09. The reason FDA records is "Calibrator C not meeting its optical density specification". 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-1031-03
Status: Terminated
Initiated: 2001-11-09
Posted: 2003-07-19
Terminated: 2006-10-03
Recalling firm: Zeus Scientific LLC
Product: Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: Calibrator C not meeting its optical density specification.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.
Quantity in commerce: 505
Distribution: The Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories.
Product codes and lots: Product Number: 507-B (Sigma Diagnostics) Lot Number: 090K6499 Expiration Date: 5-31-2002. Product Number: 2Z921M (Zeus) Lot Number: 00010446 Expiration Date: 06-09-2002

Product code DHR

K961277Class IIRF Igm Elisa Test SystemZeus Scientific, Inc. / cleared 1996-05-08

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)