VITROS 3600 Immunodiagnostic System recall
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Why was VITROS 3600 Immunodiagnostic System 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 : 36000192 36000396 36000430 36000431 36000446 36000468 36000504 36000517 36000577 36000580 36000585 36000631 36000647 36000366 36000267 36000386 36000404 36000420 36000562 36000614 36000575 36000589 36000480 36000582 36000687 36000492 36001042
- Product
- VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
- Recalling firm
- Ortho Clinical Diagnostics
- Quantity
- 27 ( U.S.= 0; OUS= 27)
- 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)