MEDLINE INDUSTRIES, LP Northfield ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
Model Number: HII1220001954, Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023), Manufacturer Number: A11A01954
Products Sold
Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954
MEDLINE INDUSTRIES, LP Northfield is recalling ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 due to Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the result. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC
Page updated: Jan 10, 2026