Reported Jun 1, 2022 · Terminated
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
ABX Pentra Calcium AS CPReagent 90 mLREF A11A01954
- Lot codes and dates
- Model NumberHII1220001954
- Lot Numbers
215907578 (Expiration Date 09/30/2022)215907729 (Expiration Date 02/28/2023)
- Manufacturer NumberA11A01954
- Amount recalled
- 6 boxes
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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