FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
- Recall number
- Z-1140-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
- Status
- Terminated
- Initiated
- 2021-10-22
- Posted
- not on file
- Terminated
- 2023-01-04
- Reason
- 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.
- Root cause
- Process control
- Action
- Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed.
- Quantity
- 6 boxes
- Distribution
- US Distribution to North Carolina.
- Lot, serial or model codes
- Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954
- 510(k) numbers
- ["K060205"]
- PMA numbers
- not on file
- Product code
- CIC
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28