Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Met

FDA device recall Z-1316-06 · posted 2006-08-02 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing).

Action taken

The firm apprised their customers of this situation with a letter dated 5/24/2005. The letter requests that the customer remove the old (incorrect) package insert and replace it with a new (correct) insert which accompanied the customer letter. Should the customer have any questions, or need additional package inserts, the letter provides a toll-free contact telephone number.

Root cause

Other

Status

Terminated

Product code

GKF

Quantity affected

55 boxes x 1 package insert per box

Distribution

Nationwide, including: PA, MI, NY, OH, NJ, TX, AL, MO, AR, TN, WA, KY, and NC, and London, ON, Canada

Date initiated

2005-05-24

Date posted

2006-08-02

Date terminated

2012-02-24

Location

Westlake, OH