Z-0489-2019Class II

Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model...

Name: Z-0489-2019 Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model...
Creator: Merck Millipore Ltd.
Published: 2018-05-14
License: https://open.fda.gov/license/

Merck Millipore Ltd. / initiated 2018-05-14 / Terminated / root cause: manufacturing process

FDA source

Merck Millipore Ltd. began a recall of Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are... on 2018-05-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0489-2019
Classification: Class II
Status: Terminated
Initiated: 2018-05-14
Posted: 2018-11-20
Terminated: 2021-08-05
Recalling firm: Merck Millipore Ltd.
Product: Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.
Product code: JJH Clinical Sample Concentrator
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 14, 2018, the firm sent an "Urgent Field Safety Notice" to customers via email and following up with a hard-copy letter on June 6, 2018 via United States Postal Services. The letter described the product, problem and actions to be taken. The corrective action being taken by the firm is to reduce the shelf life of the device from 12 months to 6 months. The customers are being instructed to immediately examine their inventory to determine if they have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. In addition, if the customer has further distributed this product, please identify its customers and notify them at once of this issue. The notification to their customers should include a copy of this notification and attachment 2 Customers are instructed to please stop use of these lots if older than 6 months and destroy any remaining inventory older than 6 months, and to complete and return the receipt confirmation form to [email protected]. If you would like more information regarding this notification, please contact us at [email protected] or go to our website to find the phone number of your local office at www.emdmillipore.com/offices.
Quantity in commerce: 1360 units
Distribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK,OR, PA, RI, TN, TX, VA, VT, WA and WI; and countries of: Canada and Australia.
Product codes and lots: Lot/Unit Numbers 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) 9031 (Model: Minicon B-15): R7HA21782, R7HA25141, R7HA25142, R7HA25143, R7JA25144, R7JA29966, R7KA29967, R7KA37204, R7KA47996, R7KA47998, R7MA62669, R7MA62670, R7MA62671, R7MA70413, R7MA73041, R7NA73042, R7NA76185, R7NA76186, R7NA84720, R7PA90587, R7PA90588, R7SA03064, R8AA13174, R8AA13175, R8AA13176, R8AA17729 9051 (Model: Minicon CS-15): R7HA32882, R7HA33739, R7HA33741, R7MA53165, R7MA53166, R8AA13177

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0489-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0489-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-20

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)