Z-1140-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2022
- Initiation Date
- October 22, 2021
- Termination Date
- January 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 boxes
Product Description
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
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.
Distribution Pattern
US Distribution to North Carolina.
Code Information
Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954