medical Class II Updated 2022-06-01

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

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: US Distribution to North Carolina.
Lot/Code Info: Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954
View official government recall

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