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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
Letter
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
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