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

FDA device recall Z-0937-2014 · posted 2014-02-06 · Terminated

Recall details

Recalling firm

ITC-Nexus Dx

Reason for recall

ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

Action taken

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: RA@itcmed.com 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 Techsupport@itcmed.com.

Root cause

Device Design

Status

Terminated

Product code

GFO

Quantity affected

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.

Date initiated

2013-12-19

Date posted

2014-02-06

Date terminated

2014-10-30

Location

Edison, NJ

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