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.
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.
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.
The reagent was shipped without refrigeration (ice) as required. This causes quality control failure, leading to inaccurate calcium test results. Patients may need repeat blood draws and testing, causing additional pain and cost.
Patients using this reagent for calcium testing may experience inaccurate results. Those who received the product between July and August 2021 are most at risk.
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.
Look for lot numbers 215907578 (expires 09/30/2022) or 215907729 (expires 02/28/2023) on the reagent bottle.
The reagent was shipped at room temperature instead of refrigerated, causing quality control failure and inaccurate test results.
Check the lot number. If it matches 215907578 or 215907729, contact Medline for instructions.
Yes, if the reagent was used, it may cause inaccurate calcium test results requiring repeat blood draws.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1140-2022 — Medline Medline Hello, I own a Medline that is covered by recall Z-1140-2022 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
