Vitros™ Chemistry Products Sali Slides
Ortho Diagnostic Systems Inc is recalling VITROS Chemistry Products SALI Slides that were distributed to hospitals, pharmacies, and laboratories in New Zealand. The manufacturer will be issuing guidance on how to use these products. This is classified as a Class I recall, the most serious type.
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS™ Chemistry Products SALI Slides. [Device]. Model: Catalog number - 131 4343 (10758750008773). Affected: Affected GENs - 04 and above
- Reason
- The manufacturer has identified an issue involving Condition Code TH4-63J, which may lead to calibration failures and/or an inability to generate patient results using VITROS™ Chemistry Products SALI Slides lots from Generations (GENs) 04 and above, on VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-05-22
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/47db646a-f328-40b0-8922-f69a7f2bafa9