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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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Event Detail

Event ID 37530
Product Type Devices
Status Completed
Recalling Firm Radiometer America Inc
City Westlake
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2006-06-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed to KY, NC, and NY.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers. Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008. Class III 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. 840 Ampules Z-0608-2013