The product is used for the evaluation of the intrinsic recall: Contamination
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Why was The product is used for the evaluation of the intrinsic recalled?
Potential for microbial contamination.
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?
Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
- Product
- The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 7,720 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.
- Recall date
- January 21, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)