HemosIL ReadiPlasTin recall
HemosIL ReadiPlasTin, Part No. 0020301400
Why was HemosIL ReadiPlasTin recalled?
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
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?
UDI 08426950632887 All in-date lots are affected by this recall.
- Product
- HemosIL ReadiPlasTin, Part No. 0020301400
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 1,563 (US); 29,046 (OUS)
- Distribution
- US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)