SPOTCHECK System
Brand(s)
Last updated
Summary
Product
SPOTCHECK System
Issue
Medical devices - Performance
What to do
Provide supplemental TCA to add so that the reagent has acceptable normality and works as intended.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| SPOTCHECK System | 240113 | 81-8000-60K |
Issue
Possible defectiveness of the TCA reagent (trichloroacetic acid) has been reported for the SPOTCHECK biotinidase microplate reagent kit.
The reagent TCA, 81-8080-100c, lot #: 240108 is the affected lot.
Recall start date: July 30, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Astoria-Pacific, Inc.
15130 Se 82nd Drive, Clackamas, Oregon, United States, 97015
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75950
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