Z-3051-2011

"BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit...

Name: Z-3051-2011 "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit...
Creator: Bio-Rad Laboratories
Published: 2010-06-30
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-06-30 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories began a recall of "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides and substrate. For use as an indirect... on 2010-06-30. The reason FDA records is "KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides". 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-3051-2011
Status: Terminated
Initiated: 2010-06-30
Posted: 2011-08-22
Terminated: 2011-08-22
Recalling firm: Bio-Rad Laboratories Inc.
Product: "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.
Product code: DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Reason for recall: KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Bio-Rad Laboratories notified affected customers by phone on 6/30/2010 and followed up with a 2nd call on 7/13/2010. The call informed customers of the problem with the kit and requested they destroy the Crithidia slide packs. Bio-Rad send out replacement slide packs. For information or questions on this recall call Bio-Rad at (425) 498-1709.
Quantity in commerce: 224 kits were distributed; 35 of those kits were determined to contain the wrong slides.
Distribution: Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico.
Product codes and lots: MSK catalog number: 30443. Lot number: 101941. Slide Pack Lot number: 00100889006.

Product code DHN

K813592Class IIQuantafluor Fluorescent Test ReagentsKallestad Laboratories, Inc. / cleared 1982-01-18

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)