iQ200 Series Urine Microscopy Analyzer recall
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322…
Why was iQ200 Series Urine Microscopy Analyzer recalled?
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
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?
UDI: 10837461001317, 10837461001355, 10837461001256,10837461001300; All Part Numbers
- Product
- iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 6601 devices
- Distribution
- Worldwide distributions.
- Recall date
- February 5, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)