GEM Check Coag CNTRL Normal APTT Whole Blood Controls… recallZ-2107-2010 · International Technidyne Corporation · initiated Jul 8, 2010
Terminated All recalls posted in July 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from International Technidyne Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-2107-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 8, 2010
- Posted by the FDA
- Jul 28, 2010
- Recalling firm
- International Technidyne Corporation
- Quantity
- 95 kits C9GC5001; 32 kits G9GC5003; 46 kits J9GC5004; 5 kits C0GC5001; Each kit contains 15 vials.
- Product code
- GGN
- FDA submissions
- K944691
- Distribution
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Part Number 06260061600; Lot C9GC5001, Exp. 7/31/2010; G9GC5003, Exp 1/31/2011; J9GC5004, Exp 3/31/2011; and C0GC5001, Exp 10/31/2011.
Other devices under the same FDA submission
1 device cleared under K944691 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- directCHECK Whole Blood Controls DCJCPT-AAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 56169).
- Z-2108-2010 · TerminatedGEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125. I…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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