The ABL800 recall
The ABL800 Model#:All
Why was The ABL800 recalled?
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
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?
The affected analyzers are serial numbers 393-090R0027N001 to present.
- Product
- The ABL800 Model#:All
- Recalling firm
- Radiometer America Inc
- Quantity
- 17,522
- Distribution
- U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
- Recall date
- March 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)