Z-2428-2008

Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line...

Name: Z-2428-2008 Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line...
Creator: Bio-Rad Laboratories
Published: 2008-07-29
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2008-07-29 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories began a recall of Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA... on 2008-07-29. The reason FDA records is "The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit". 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-2428-2008
Status: Terminated
Initiated: 2008-07-29
Posted: 2008-09-19
Terminated: 2011-03-31
Recalling firm: Bio-Rad Laboratories Inc.
Product: Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog #: 30471 - 12 well kit, 60 tests; 30472 - 12 well kit, 240 tests; and 32583 - 6 well kit, 48 tests.
Product code: DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Reason for recall: The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 7/25/08, the firm began to notify their customers about the recall via an Urgent Product Correction sent by DHL or FEDEX. Included with the customer letter was a revised QC Card. International subsidiaries were notified by e-mail with the customer letter and revised QC Card attached. The letter informed customers of the recall and directing them to the revised QC card which was attached to the letter. The instructions are to, "Please use this to replace the card in any kits remaining in your facility." If customers have any questions or require additional QC cards, they are to contact Technical Support.
Quantity in commerce: 4,400 total kits
Distribution: Worldwide Distribution --- including USA and countries of AUSTRALIA, BRAZIL, CANADA, CHINA , FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, MEXICO, NEW ZEALAND, POLAND, SINGAPORE, SOUTH KOREA , TAIWAN, UNITED KINGDOM, and URUGUAY.
Product codes and lots: Lot # and exp: For catalog # 30471: 951567, exp 2/28/09; 954479, exp 12/31/08; 954566, exp 11/30/08; 954895, exp 3/31/09; 955422, exp 2/28/09; 955495, exp 2/28/09; for catalog # 30472: 951564, exp 2/28/09; 954135, exp 2/28/09; 954481, exp 3/31/09; 954567, exp 3/31/09; 954858, exp 3/31/09; 954927, exp 3/31/09; 955197, exp 4/30/09; and for catalog # 32583: 951566, exp 2/28/09.

Product code DBM

K810863Class IIKallestad Hep-2 Cell Line SubstrateKallestad Laboratories, Inc. / cleared 1981-04-14

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)