FDA recall, , Moderate risk
Accriva Diagnostics Hemochron Jr. APTT Test Cuvettes
The Hemochron Jr. APTT test cuvette may have a mispositioned or absent reagent, causing erroneous results and potential thrombosis.
Summary by Recall Canary from the FDA notice
What happened
Accriva Diagnostics, Inc., of San Diego, California, is voluntarily recalling the Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103.
The microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in an out-of-range high error code, or erroneously high results. These results may lead to a retest, or an overestimation of the patient's anticoagulation, leading to inadequate anticoagulant therapy, which could result in thrombosis.
The company began the recall on September 14, 2026, and the FDA added it to the Enforcement Report on October 30, 2026. Distribution was worldwide, including nationwide in the states of MA, MO, AK, WV, NJ, TX, VA, IL, NY, and the countries of China and Colombia. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette
- UDI-DI
- 10711234103012
- Reference number
- J103
- Lot code
- B6JCA005
- C6JCA008
- D6JCA011
- K5JCA041
- C6JCA007
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Worldwide - US Nationwide distribution in the states of Massachusetts, Missouri, Alaska, West Virginia, New Jersey, Texas, Virginia, Illinois, New York and the countries of China, Colombia.
- Recalled by
- Accriva Diagnostics, Inc.San Diego, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99863
- Recall number
- Z-0317-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Accriva Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Accriva Diagnostics began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
