iQ200 Series Urine Microscopy Analyzer: a) iQ 200 recall
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375…
Why was iQ200 Series Urine Microscopy Analyzer: a) iQ 200 recalled?
Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
a) iQ 200 Select, Part Numbers C10684, UDI/DI 15099590695484 and 700-3345, UD/DI 10837461001300; b) iQ 200 Elite, Part Numbers C10683, UDI/DI 15099590697129 and 700-3375, UDI/DI 10837461001355; c) iQ200 Select 1500, Part Number 700-3347, UD/DI 10837461001317; d) iQ200 Sprint, Part Number 700-3325, UDI/DI 10837461001256; All analyzers with Windows 10, Software Version 8.1;
- Product
- iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375…
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 1068 units
- Distribution
- Worldwide Distribution
- Recall date
- May 24, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)