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MEDLINE INDUSTRIES, LP - Northfield recalls ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

Recalled June 1, 2022 · FDA recall Z-1140-2022 · 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. · FDA Class II
Units
6 boxes
Sold at
US Distribution to North Carolina.

Description

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.

Product
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

MEDLINE INDUSTRIES, LP - Northfield recalls ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 | RecallWatchUSA