Radiometer America Inc: Medical Device Recall in 2013 - (Recall #: Z-0608-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: June 6, 2006

Date Posted: January 2, 2013

Recall Number: Z-0608-2013

Event ID: 37530

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.

Status: Terminated

Product Quantity: 840 Ampules

Code Information:

Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.

Distribution Pattern:

Distributed to KY, NC, and NY.

Voluntary or Mandated:

Voluntary: Firm initiated