Infinity Ammonia Standard Set
- Recalling firm
- Thermo Fisher Scientific New Zealand Ltd
- Product
- Infinity Ammonia Standard Set. [Device]. Model: Catalog number: TR60901 - Lot number: 382963, 364987, 307166
- Reason
- The manufacturer has identified that elevated levels of ammonia may be either: (a) due to inborn errors of metabolism; or (b) secondary to other conditions, such as viral hepatitis or cirrhosis. This Standard is not a companion diagnostic, nor is it intended for use in a specific population. This reagent is intended to be an aid to diagnosis, for laboratory professional use only., A complaint was received from a customer reporting approximately 6% to 15% low calibration bias after switching ammonia standard lots and attributed the bias to the calibrators., This issue may lead to prognostic...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-11-02
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/8c627164-3fb1-4b8d-8b03-9d67614c0ba6