Accriva Diagnostics, Inc.: Plasma, Coagulation Control
Accriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control (level 2) because the product labeling lists an incorrect performance range. This product is a quality control material used in coagulation testing and was distributed nationwide in the US, as well as in Canada, Hong Kong, and Spain. The recall is classified as Class II, meaning the product could potentially cause adverse health effects or serious issues if the incorrect range information is used.
- Recalling firm
- Accriva Diagnostics, Inc.
- Product
- directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
- Reason
- Assayed Whole blood control contains labeling with incorrect performance range.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hong Kong, Spain.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/78d8adc5-f8d3-48da-8639-e69bef394a3f