Reported Nov 28, 2018 · Terminated
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon…
Merck Millipore Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merck Millipore Ltd. · Tullagreen Carrigtwohill · County Cork, N/A · N/A
Is this the product you have?
- Minicon Clinical Sample Concentrators
- for In Vitro Diagnostic Use 9031 (ModelMinicon
- B-15) & 9051 (ModelMinicon 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
- Lot codes and dates
- Lot/Unit Numbers 9031 (ModelMinicon
- B-15) & 9051 (ModelMinicon
- CS-15) 9031 (ModelMinicon
- B-15)
R7HA21782R7HA25141R7HA25142R7HA25143R7JA25144R7JA29966R7KA29967R7KA37204R7KA47996R7KA47998R7MA62669R7MA62670R7MA62671R7MA70413R7MA73041R7NA73042R7NA76185R7NA76186R7NA84720R7PA90587R7PA90588R7SA03064R8AA13174R8AA13175R8AA13176
- R8AA17729 9051 (ModelMinicon
- CS-15)
R7HA32882R7HA33739R7HA33741R7MA53165R7MA53166R8AA13177
- Amount recalled
- 1360 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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