VITROS 5600 Integrated System Software Versions 3.3.3 recall
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Why was VITROS 5600 Integrated System Software Versions 3.3.3 recalled?
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Affected Serial Number Range : J56000114- J56001879
- Product
- VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
- Recalling firm
- Ortho Clinical Diagnostics
- Quantity
- 2617 units (U.S.=1272; OUS=1344)
- Distribution
- US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN
- Recall date
- July 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)