Specialty Immunoassay Control
Bio-Rad Laboratories is recalling Specialty Immunoassay Control products distributed to hospitals, pharmacies, and laboratories in New Zealand because the instructions for use need to be updated. This is classified as a Class I recall, the most serious type. The products affected are Specialty Immunoassay Control items used in laboratory testing.
- Recalling firm
- Bio-Rad New Zealand
- Product
- Specialty Immunoassay Control. [Device]. Model: nteliQ Specialty Immunoassay Control, lot 10460T and Liquichek Specialty Immunoassay Control, lot 1003760 series
- Reason
- The manufacturer is notifying customers of a lot-specific change affecting Intact (iPTH) in InteliQ Specialty Immunoassay Control lot 10460T and Liquichek Specialty Immunoassay Control lot series 1003760, specifically relating to the thawed unopened and thawed opened stability claims., The manufacturer is requesting that customers potentially affected take the following actions:, � Obtain the revised package insert and discard all previous versions that you may have at your location.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-06-08
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/529d6a9d-313f-48ab-8bc1-b4c564f5df5c