"BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides
FDA device recall Z-3051-2011 · posted 2011-08-22 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories
- Reason for recall
- KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
- Action taken
- 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
- Status
- Terminated
- Product code
- DHN
- Quantity affected
- 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.
- Date initiated
- 2010-06-30
- Date posted
- 2011-08-22
- Date terminated
- 2011-08-22
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUANTAFLUOR FLUORESCENT TEST REAGENTS (K813592) | Kallestad Laboratories, Inc. | 1982-01-18 |