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U.S. Department of Health and Human Services

Class 2 Device Recall ACCUCHEK

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 Class 2 Device Recall ACCUCHEKsee related information
Date Initiated by FirmJune 22, 2006
Date PostedAugust 05, 2006
Recall Status1 Terminated 3 on April 07, 2008
Recall NumberZ-1365-06
Recall Event ID 35022
510(K)NumberK983047 
Product Classification Blood Glucose Meter - Product Code LFR
ProductACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and Communication; Contents include two Accu-Chek Advantage monitors including Cat. no. 2138018 and Cat. no. 2138026. Ref. nos. 12138018001 and 12218542001 both include include meters with model number 777.
Code Information All units.
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
For Additional Information Contact
800-440-3638
Manufacturer Reason
for Recall		The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
FDA Determined
Cause 2		Other
ActionA recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.
Quantity in Commerce55,189 meters (for all Recalls Z-1354-1371-06)
DistributionWorldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LFR
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