FDA Device recall Z-1140-2022
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
- FDA Device
- Class II
- terminated
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 by Medline Industries Northfield, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1140-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-22 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | NC |
Product
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
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.
Identifiers
| code_info | Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1140-2022%22
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