Z-1316-06

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

Name: Z-1316-06 Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of...
Creator: Radiometer America Inc
Published: 2005-05-24
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-05-24 / Terminated / root cause: labeling and UDI

FDA source

Radiometer America Inc began a recall of Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555... on 2005-05-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1316-06
Status: Terminated
Initiated: 2005-05-24
Posted: 2006-08-02
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
Product: Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.
Product code: GKF Instrument, Hematocrit, Automated
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).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 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
Product codes and lots: Model #.S7180, Part Number: 944040, Lot #15.

Product code GKF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)