HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent

FDA device recall Z-0832-2015 · posted 2014-12-19 · Terminated

Recall details

Recalling firm

Instrumentation Laboratory Co.

Reason for recall

Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.

Action taken

The firm, Instrumentation Laboratory, sent an "URGENT MEDICAL DEVICE CORRECTION" letter (dated 11/21/2014) to US and Canadian customers via USPS on 11/21/2014 for all in-date lots of HemosiL PT-Fibrinogen HS PLUS, Part No. 0008469810, manufactured prior to June 2014. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: if they observe any yellow/brownish color after reconstitution, they are not to use the affected vial; discard the vial and reconstitute another vial; only use a vial if the reconstituted color is the typical white to off-white color; run quality controls at least once every 8 hour shift in accordance with GLP and insert instruction sheet; share this information with your laboratory staff and follow initial procedures; forward this notification to all affected locations within your facility; retain a copy of this notification for your records and complete and return the tracking record form within 10 business days of receiving notification even if you do not use these reagents via fax at 781-861-4207 or email to: ra-usa@ilww.com. On 11/21/2014, e-mail notifications were sent to the IL/Werfen Country Affiliates and International Group (who manage the local country dealers and distributors) to prepare and issue Field Safety Notices in the respective languages to their customers. For technical questions, please contact the IL Technical Support Center at 1-800-678-0710, Option # 2 (ACL Coagulation Products). For additional questions, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 2.

Root cause

Process design

Status

Terminated

Product code

GJS

Quantity affected

USA: 4088 kits; Foreign: 97,925 kits

Distribution

Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COL

Date initiated

2014-11-21

Date posted

2014-12-19

Date terminated

2016-01-26

Location

Bedford, MA

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