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U.S. Department of Health and Human Services

Class 3 Device Recall Qualicheck 1, Aqueous Quality Control, Level 2, S7140, REF 944042.

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 Class 3 Recall
Qualicheck 1, Aqueous Quality Control, Level 2, S7140, REF 944042.
see related information
Date Posted December 21, 2012
Recall Status1 Terminated on February 05, 2013
Recall Number Z-0608-2013
Recall Event ID 37530
Premarket Notification
510(K) Number
K771444 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Code Information Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
Recalling Firm/
Manufacturer
Radiometer America Inc
810 Sharon Dr
Westlake, Ohio 44145-1598
Consumer Instructions Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.
For Additional Information Contact Vincent Sigmund
440-871-8900 Ext. 209
Manufacturer Reason
for Recall
The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Radiometer sent Field Action Notes regarding the affected product. The note identified the product, the problem and the action to be taken by the customer. Instead of scanning the barcorde on the insert to enter the QC data into the anyalyzer, customers were instructed to manually key in the QUALICHECK type, lot number, and correct control range. For questions regarding this recall call 440-871-8900.
Quantity in Commerce 840 Ampules
Distribution Distributed to KY, NC, and NY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = THE LONDON CO.
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