ABL800 analyzer recall: Software Issue
ABL800 analyzer, model numbers 393-800 and 393-801.
Why was ABL800 analyzer recalled?
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
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?
Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.
- Product
- ABL800 analyzer, model numbers 393-800 and 393-801.
- Recalling firm
- Radiometer America Inc
- Quantity
- 2,131 analyzers
- Distribution
- Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
- Recall date
- January 2, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)