FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories: "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.
- Recall number
- Z-3051-2011
- Recalling firm
- Bio-Rad Laboratories
- 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.
- Status
- Terminated
- Initiated
- 2010-06-30
- Posted
- 2011-08-22
- Terminated
- 2011-08-22
- Reason
- KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
- 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
- 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.
- Lot, serial or model codes
- MSK catalog number: 30443. Lot number: 101941. Slide Pack Lot number: 00100889006.
- 510(k) numbers
- ["K813592"]
- PMA numbers
- not on file
- Product code
- DHN
- Firm FEI
- 3008272466
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28