Health product recall

Spotcheck - Neonatal Galt Microplate Reagent Kit

Last updated

Summary

Product
Spotcheck - Neonatal Galt Microplate Reagent Kit
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Spotcheck - Neonatal Galt Microplate Reagent Kit

231011
230813

81-4061-00K
81-4000-60K

Issue

On Nov. 28, 2023, a customer notified manufacturer that the NADH stock standard included in the Neonatal Galt Microplate Reagent Kit was not working as expected. Manufacturer determined that NADH stock standard, lot 230813, was manufactured with the incorrect fill quantity. Neonatal Galt Microplate Reagent Kit, lot 231011, contains the defective NADH stock standard regent, lot 230813.

Recall start date: November 28, 2023

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-74835

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