i-STAT cTnI cartridge recall
i-STAT cTnI cartridge
Why was i-STAT cTnI cartridge recalled?
i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
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?
List Number: 06P23-25 UDI: (01)00054749001986
- Product
- i-STAT cTnI cartridge
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 3,465,875
- Distribution
- US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY
- Recall date
- January 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)