Lower risk Medical device recall · FDA · Published October 22, 2021

Medline ABX Pentra Calcium Reagent Recall: Incorrect Shipping Causes Test Errors

Medline recalls ABX Pentra Calcium AS CP reagent due to shipping at room temperature instead of refrigerated, risking inaccurate test results and repeat blood draws. Affected lots shipped between July-August 2021.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1140-2022Medical device Medline ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753

✎ GovInfoNow plain-language explainer

Medline is recalling ABX Pentra Calcium AS CP reagent that was shipped at room temperature instead of refrigerated. This could cause inaccurate test results, requiring repeat blood draws and causing patient inconvenience and additional costs. Read more at govinfonow.com/recall/61635-medline-abx-pentra-calcium-reagent-recall-incorrect-shipping-causes-test.

Source Summary by GovInfoNow · govinfonow.com/recall/61635-medline-abx-pentra-calcium-reagent-recall-incorrect-shipping-causes-test · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1140-2022

Cite this page

“Medline ABX Pentra Calcium Reagent Recall: Incorrect Shipping Causes Test Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61635-medline-abx-pentra-calcium-reagent-recall-incorrect-shipping-causes-test. Based on FDA recall #Z-1140-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1140-2022%22&limit=1).

The FDA announced on 2021-10-22 that Medline Industries, LP recalled ABX Pentra Calcium AS CP reagent due to improper storage at room temperature. This error may cause quality control failures and delay diagnosis for patients. The agency classified the recall as Class II.

How to tell if you have it

Brand: Medline
Product: ABX Pentra Calcium AS CP, Reagent 90 mL
REF: A11A01954
Model Number: HII1220001954
Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023)
Distribution: US Distribution to North Carolina
Units affected: 6 boxes shipped to end users

The hazard

GovInfoNow's records show the product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated. If used, results will not be provided due to probable quality control failure. This may cause patient inconvenience, pain, and cost of repeat blood draw and testing.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has had 119 other recalls on record since 2021-11-30. Other recent recalls include Medline medical kits recalled on 2025-07-25 for light failure in intubation trays and Medline Recalls Foley Tray Kits with Incorrect Labeling Risk on 2025-07-23. Similar recent recalls of similar products include Bioporto ProNephro AKI Reagent Kit Recall (2026-05-18), Medline Convenience Kits Recall (2026-05-21), and Copan Italia DTT Liquid Reagent Recall (2025-10-29).

How to tell if you have this one

Check for lot numbers 215907578 (expires 09/30/2022) or 215907729 (expires 02/28/2023). Products shipped by Medline between July and August 2021 are affected.

Brand
Medline
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 215907578 (expires 09/30/2022) or 215907729 (expires 02/28/2023) on the reagent bottle.

Where it went and when

Where it was distributed

Distributed in North Carolina.

FDA distribution: “US Distribution to North Carolina.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: North Carolina.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

Oct 22, 2021Firm started the recall
May 26, 2022FDA classified it Class II
Jun 1, 2022Published in FDA’s Enforcement Report
Jan 4, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Medline recalls

Link to this recall

<a href="https://govinfonow.com/recall/61635-medline-abx-pentra-calcium-reagent-recall-incorrect-shipping-causes-test">Medline ABX Pentra Calcium Reagent Recall: Incorrect Shipping Causes Test Errors (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1140-2022 (October 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1140-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.