FDA-Device2022-06-01Class II

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

MEDLINE INDUSTRIES, LP - Northfield

Hazard

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

Sold states

US Distribution to North Carolina.

Affected count

6 boxes

Manufactured in

3 Lakes Dr, Northfield, IL, United States

Products

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1140-2022

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