MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2022 - (Recall #: Z-1140-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 22, 2021

Date Posted: June 1, 2022

Recall Number: Z-1140-2022

Event ID: 90126

Reason for Recall:

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.

Status: Terminated

Product Quantity: 6 boxes

Code Information:

Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954

Distribution Pattern:

US Distribution to North Carolina.

Voluntary or Mandated:

Voluntary: Firm initiated