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Class 2 Device Recall in2it Self Test System A1c Test Cartridge |
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Date Initiated by Firm |
July 26, 2010 |
Date Posted |
October 22, 2010 |
Recall Status1 |
Terminated 3 on October 25, 2011 |
Recall Number |
Z-0122-2011 |
Recall Event ID |
56503 |
510(K)Number |
k041635
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Product Classification |
Assay, glycoslylated hemoglobin - Product Code LCP
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Product |
in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK The in2it (I) and (II) is an affinity chromatography method and is intended for the in-vitro quantitative determination of A1c in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood Glucose levels of known diabetics, for professional use as an indicator of overall glycemic control. The in2it (I) assay is intended for use in a physicians/doctors' office, the in2it (II) is intended for home use. The in2it Self Test system in intended for testing blood taken from a fingerstick. The test system is for self testing and for in-vitro diagnostic use only (not to be swallowed). The system shows how good glucose control has been over a two to three month period. The test system is the same as the test that has been CE marked for use in a clinical laboratory. The instructions for use have been changed with suggestions from people with diabetes. A patient study was conducted where untrained users ran their own blood tests and produced results which were as accurate as results obtained by trained users. |
Code Information |
Catalog numbers 281-0001EX, 281-0001, and 281-0001ST, all product manufactured sinc 2007-09-20. |
Recalling Firm/ Manufacturer |
Bio-Rad Laboratories Inc 4000 Alfred Nobel Dr Hercules CA 94547-1803
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For Additional Information Contact |
510-724-7000
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Manufacturer Reason for Recall |
Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.
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FDA Determined Cause 2 |
Device Design |
Action |
BIO-RAD Laboratories Deeside Ltd., sent an URGENT: MEDICAL DEVICE CORRECTION letter, dated July 26, 2010, to their subsidiaries and to all customers identifying the product, the problem, and the action to be taken. Subsidiaries were to ensure that all customers received the letter with the Customer Medical Device Correction Response Form and collect the completed form from every customer. Once forms were received from all customers they were to be faxed to BIO-RAD Deeside Regulatory Affairs at +44 (0) 1244833401.
Customers were instructed to run a test and visually inspect the test cartridge to detect any residual clear liquid. If the cartridge did not run properly the test was to be rejected.
Customers were to run Quality Control test with each new shipment of test cartridges.
Patient's results were not to be reported if the QC failed.
Customers were to complete the CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the number provided on the form.
For questions customers were to contact their regional BIO-RAD office. |
Quantity in Commerce |
90703 |
Distribution |
Product was distributed to Bio-Rad's US subsidiary, along with 18 other distribution subsidiaries outside the US. These distributed further to other consignees. POroduct was distributed to Mexico, Korea, Singapore, Italy, South Africa, India, Australia, Spain, Greece, France, Thailand, Germany, New Zealand, China, Hong Kong, Portugal, Czech Republic, United Kingdom, Canada, Russia, Netherlands, Taiwan, Austria, Denmark, Israel, Finland and Belgium as well as to other African and Latin American countries. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LCP and Original Applicant = PROVALIS DIAGNOSTICS LTD.
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