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U.S. Department of Health and Human Services

Class 2 Device Recall in2it (I) and (II) Test Cartridges

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  Class 2 Device Recall in2it (I) and (II) Test Cartridges see related information
Date Initiated by Firm September 07, 2010
Date Posted October 21, 2010
Recall Status1 Terminated 3 on May 17, 2011
Recall Number Z-0109-2011
Recall Event ID 56762
510(K)Number K041635  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA.

The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) 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.
Code Information Product code LCP,expiration dates between 2011-07-12 and 2011-07-26. Kit lot numbers (I):072T97, 072T98, 072T100, (II): 074P75, 074P73, Device lot numbers 131Q203 38864, 131Q204 39008, 131Q206 39088
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
Manufacturer Reason
for Recall
Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.
FDA Determined
Cause 2
Component design/selection
Action BIO-RAD Laboratories Deeside sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated September 7, 2010, via registered mail to all subsidiaries/customers. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to stop using and discard the test cartridges from the listed lots; complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax +44 1244 833401; record the number of affected kits of product, confirm that they have discarded the cartridges and record the method of disposal. If you have any questions, contact +44 1244 288888.
Quantity in Commerce 4056
Distribution Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Philippines.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = LCP and Original Applicant = PROVALIS DIAGNOSTICS LTD.