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U.S. Department of Health and Human Services

Class 2 Device Recall MULTIGENT Acetaminophen for use with Architect/Aeroset

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 Class 2 Device Recall MULTIGENT Acetaminophen for use with Architect/Aerosetsee related information
Date Initiated by FirmMay 29, 2012
Date PostedJune 27, 2012
Recall Status1 Terminated 3 on November 14, 2012
Recall NumberZ-1902-2012
Recall Event ID 62017
510(K)NumberK042330 
Product Classification Colorimetry, acetaminophen - Product Code LDP
ProductMULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Code Information Lot 41928UQ11 {exp 2013-01 -31 ) 
Recalling Firm/
Manufacturer		 Sekisui Diagnostics Llc
31 New York Ave
Framingham MA 01701-8860
For Additional Information Contact
508-661-1154
Manufacturer Reason
for Recall		Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
FDA Determined
Cause 2		Storage
ActionSekisui Diagnostics Llc sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop using the affected product and to destroy any remaining inventory. A Confirmation of Notification Form was attached for customers to complete and return via fax to 902-628-6504. Contact the firm at 902-628-0984 for questions regarding this notice.
Quantity in Commerce1600 kits
DistributionIllinois
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 = LDP
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