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U.S. Department of Health and Human Services

Class 2 Device Recall Hemochron Jr. Microcoagulation System Activated Partial Thromboplastin Time (APTT) Test Cuvette

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 Class 2 Device Recall Hemochron Jr. Microcoagulation System Activated Partial Thromboplastin Time (APTT) Test Cuvettesee related information
Date Initiated by FirmSeptember 14, 2026
Date PostedOctober 30, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0317-2027
Recall Event ID 99863
510(K)NumberK940401 
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
ProductHemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
Code Information UDI-DI: 10711234103012, Lot(Expiration): B6JCA005(02/28/2027), C6JCA008(03/31/2027), D6JCA011(04/30/2027), K5JCA041(10/31/2026), C6JCA007(03/31/2027)
FEI Number 2250033
Recalling Firm/
Manufacturer		 Accriva Diagnostics, Inc.
6260 Sequence Dr
San Diego CA 92121-4358
For Additional Information ContactPaula Morgan
858-263-2590
Manufacturer Reason
for Recall		Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high results, which may lead retest, or overestimation of patient's anticoagulation, leading to inadequate anticoagulant therapy, which could result in thrombosis.
FDA Determined
Cause 2		Process control
ActionOn 9/14/2026, recall notices were mailed to customers who were informed of the following: 1) Please forward this communication to those within your organization who need to be aware of this matter and verify they understand the procedure and can complete the enclosed forms. 2) Forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3) Please check your inventory and do not use affected lots. 4) Scrap/destroy all impacted cuvettes and/or boxes. 5) Complete and return the Acknowledgement and Receipt Form via email to ilsd_ra.na@werfen.com Questions about receiving credit, should be directed to Customer Service at 1-800-955-9525 or e-mail customerservice.na@werfen.com. Technical questions should be directed to Technical Services at 1-800-678-0710 Option 3 or email techsupport.na@werfen.com.
Quantity in Commerce28710
DistributionWorldwide - US Nationwide distribution in the states of MA, MO, AK, WV, NJ, TX, VA, IL, NY and the countries of China, Colombia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JPA
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