Rida®plex Respiratory Pathogens C 16 Well Step 1
Recall Summary AusDiagnostics is recalling RIDA®Plex Respiratory Pathogens C 16 well Step 1 (Lot S3520206), a respiratory disease testing device distributed to hospitals, pharmacies, and laboratories in New Zealand. The device has increased background signal in the RSV-A/B detection channel that may cause incorrect test results, including false positive readings for respiratory syncytial virus. This is a Class I recall, indicating the highest level of concern.
- Recalling firm
- AusDiagnostics NZ Ltd
- Product
- RIDA®Plex Respiratory Pathogens C 16 well Step 1. [Device]. Affected: Affected Lot S3520206
- Reason
- An increase in background signal in the RSV-A/B detection channel for affected Lot S3520206 was identified. This effect may generate atypical RSV-A/B amplification profiles resulting in incorrect RSV-A/B Check or false Positive calls.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-06-30
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/10e77056-8a2a-433d-a3e5-abb6a6623d98