Z-1720-2016Class II

Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012

Name: Z-1720-2016 Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012
Creator: Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Published: 2016-04-22
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2016-04-22 / Terminated / root cause: manufacturing process

FDA source

Accriva Diagnostics Inc., dba ITC, dba Accumetrics began a recall of Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012 on 2016-04-22. FDA classified it as Class II and gives the reason as "Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1720-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Posted: 2016-05-25
Terminated: 2016-12-14
Recalling firm: Accriva Diagnostics, Inc.
Product: Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Accriva sent an " Urgent Field Safety Notice" letter dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to take the following actions: 1. Forward communication to all those within organization who need to be aware of this matter. In addition, forward notification to all other organizations where affected devices may have been transferred to. 2. Check inventory to determine if you have any APTT Test Cuvettes, Lot Number: B6JCA012 3. If have inventory of APTT Test Cuvettes, with the subject Lot Number destroy the product and submit the attached Destruction Form along with your request for credit. 4. If have inventory DO NOT SHIP TO CUSTOMERS any kits labeled with APTT Test Cuvettes and the subject Lot Number. 5. If have shipped this product to customers please inform them immediately to STOP using the product. Provide the customers with a copy of this notification, request for the destruction of any unused product and the return of the attached forms. 6. Follow the instructions on the attached Field Corrective Action Form, complete the form and return it as instructed on the form. 7. If have questions, please contact Accriva Diagnostics directly contact information is provided below. Accriva Diagnostic, Attn: Regulatory Affairs USA Tel: 858.263.2347 Email: [email protected]
Quantity in commerce: 135 boxes
Distribution: U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
Product codes and lots: Lot #B6JCA012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1720-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1720-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-25

Product code JPA

K940401Class IIJr. Microcoagulation SystemInternational Technidyne Corp. / cleared 1994-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)