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Terminated

Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.

FDA Recall Z-0608-2013 · Posted 2012-12-21

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2006-06-06
Date Terminated2013-02-05
Product Quantity840 Ampules

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Distributed to KY, NC, and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K771444QUALICHECK TMThe London Co. · 1977-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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