The Id-card Liss/coombs

Recalling firm
Bio-Rad New Zealand
Product
The ID-Card LISS/Coombs. [Device]. Affected: lot 50531.33.32 / 0524633332
Reason
The manufacturer has identified that some units of ID-Card LISS/Coombs lot 50531.33.32 / 0524633332 may exhibit a red haze leading to uninterpretable and/or false positive results when used in instruments., During manual reading of the card, it is possible to observe a cloud above the pellet. These events occur only with wells 1, 2 and 3 of the cards. Wells 4, 5 and 6 conform to specifications.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-08-12
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/2611bed3-aa15-47ee-bb5d-fd5200e710b7