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Terminated

"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.

FDA Recall Z-3051-2011 · Posted 2011-08-22

Recalling FirmBio-Rad Laboratories
Recall StatusTerminated
Product CodeDHN
Date Initiated2010-06-30
Date Terminated2011-08-22
Product Quantity224 kits were distributed; 35 of those kits were determined to contain the wrong slides.

Reason for Recall

KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K813592QUANTAFLUOR FLUORESCENT TEST REAGENTSKallestad Laboratories, Inc. · 1982-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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