Merck Millipore recalls Minicon B-15 and CS-15 clinical sample concentrators used over 6 months after manufacture due to potential delays in diagnostic test results. Affected units have specific lot numbers.
In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentration times of greater than the specification of 3 hours and up to 24 hours, which may lead to delays in carrying out the subsequent analysis tests.
Merck Millipore is recalling Minicon B-15 and CS-15 clinical sample concentrators that have been used for more than 6 months since manufacture. These devices may cause test delays if they run longer than 3 hours, which could affect diagnostic results.
The concentrators may run longer than 3 hours when used for more than 6 months after manufacture, causing delays in diagnostic tests. This could lead to inaccurate results or missed diagnoses if the testing process is not completed on time.
Healthcare professionals and labs using Minicon B-15 or CS-15 sample concentrators that were manufactured more than 6 months ago are most at risk. These devices are used for concentrating body fluids before diagnostic testing.
Check for lot numbers starting with R7HA, R7JA, R7KA, R7MA, R7NA, or R8AA for the B-15 model (9031) and CS-15 model (9051). These units were manufactured more than 6 months ago and may have increased concentration times.
Verify if the device has been in use for more than 6 months since manufacture.
Look for specific lot numbers listed in the recall notice for affected units.
The concentrators may run longer than 3 hours when used for more than 6 months after manufacture, causing delays in diagnostic tests.
Check if your device has been in use for more than 6 months since manufacture and has a listed lot number. If so, contact Merck Millipore for further instructions.
The recall is for potential test delays, not physical safety risks. The hazard is low risk as it only affects diagnostic timing.
We’ve drafted a message you can send Merck Millipore to request your refund or repair — edit it as you like.
Subject: Recall Z-0489-2019 — Merck Millipore Merck Millipore Hello, I own a Merck Millipore that is covered by recall Z-0489-2019 from Merck Millipore. 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.
