GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
FDA Recall Z-2107-2010 · Posted 2010-07-28
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Recalling FirmInternational Technidyne Corporation
Recall StatusTerminated
Product CodeGGN
Date Initiated2010-07-08
Date Terminated2010-09-23
Product Quantity95 kits C9GC5001; 32 kits G9GC5003; 46 kits J9GC5004; 5 kits C0GC5001; Each kit contains 15 vials.
Reason for Recall
Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.
Firm Action
Urgent: Medical Device Correction Notices, dated July 1, 2010, were sent by Federal Express on July 8, 2010 to all first consignee end users. The letters identified the affected product and asked customers to review and follow all instructions as outlined in the ITC in the communication. The info should be shared with laboratory staff and the notification should be retained as part of the laboratory Quality System documentation. The enclosed response form should be completed and returned to ITC within 5 days.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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