Z-0937-2014Class II

Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in...

Name: Z-0937-2014 Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in...
Creator: ITC-Nexus Dx
Published: 2013-12-19
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2013-12-19 / Terminated / root cause: design

FDA source

ITC-Nexus Dx began a recall of Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The... on 2013-12-19. FDA classified it as Class II and gives the reason as "ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0937-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Posted: 2014-02-06
Terminated: 2014-10-30
Recalling firm: Accriva Diagnostics, Inc.
Product: Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
Product code: GFO Activated Partial Thromboplastin
Reason for recall: ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, ITC The Point of Care, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2013 a long with an attached Health Professional Account Tracking Form via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to forward this communication to all those within your organization who need to be aware of this matter including any facility that you forwarded any of the affected product to; check all inventory to determine if you have any of the affected lots listed; if you have any affected lots, stop using them, remove from inventory and return to ITC; complete the attached Health Professional Account Tracking Form and return it within 10 days via fax to: 866-429-3132, email: [email protected] or mail to: ITC Technical Support, 20 Corporate Place South - Piscataway, NJ 08854 . It is important that you complete the form whether or not you have remaining inventory of these lots. In addition, contact ITC Technical Support immediately if you become aware of an unreported adverse event related to the use of affected J103C cuvettes. ITC will review your response form and will contact you to arrange for any inventory to be returned to ITC and ITC will replace all unused, returned product. If you have questions, please contact ITC Technical Support: Telephone 800-579-2255 or 732-548-5700, Extension 4011 or E-mail [email protected].
Quantity in commerce: 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)
Distribution: Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
Product codes and lots: E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0937-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0937-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-06

Product code GFO

K014008Class IIHemochron Jr. Citrate Aptt CuvetteItc, Inc. / cleared 2002-01-24

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)