ABX Pentra Calcium AS CP — Class II medical device recall Z-1140-2022
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-06-01, distributed in NC. Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice).
| Recall number | Z-1140-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2021-10-22 |
| Classified | 2022-05-26 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2023-01-04 |
| Distributed | NC |
| Quantity | 6 boxes |
| Lot numbers | 215907578 |
| Model numbers | A11A01954, HII1220001954 |
| Expiration dates | 2022-09-30, 2023-02-28 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1140-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.