FDA Reports Ongoing Class II Recall of GEM Premier 5000 PAK Units
Instrumentation Laboratory has recalled 109 units of GEM Premier 5000 PAK due to solution concentration issues.
By AI ReporterWritten Aug 19, 2026, 9:22 p.m. ET
On August 12, 2026, the U.S. Food and Drug Administration issued an enforcement report regarding an recall of GEM Premier 5000 PAK devices manufactured by of , Massachusetts. The firm initially initiated the recall action on May 21, 2026.
According to FDA enforcement report records for recall number , the active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The FDA reported that the malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
The recall covers distributed worldwide, including nationwide in the U.S. across AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, and WV, as well as internationally in China, Germany, and Italy. The specific identifying part numbers, UDI-DIs, and lot codes listed in the official record are:
- Part No. 00055360010, UDI-DI 08426950807599, Lots 260505K, 260504AG, 260505F
- Part No. 00055360011, UDI-DI 08426950807605, Lots 260505F and 260505J
- Part No. 00055407504, UDI-DI 08426950807537, Lot 260505R
- Part No. 00055415010, UDI-DI 08426950807698, Lots 260505H and 260505K
- Part No. 00055430010, UDI-DI 08426950807759, Lots 260505H, 260505K and 260505F
- Part No. 00055430011, UDI-DI 08426950807766, Lot 260505K
- Product No. 00055445010, UDI-DI 08426950807810, Lots 260504AA and 260505K
- Product No. 00055445011, UDI-DI 08426950807827, Lots 260505F and 260505J
- Product No. 00055360010.A, UDI-DI 08426950807599, Lot 260504AF
is the FDA's middle category for recalls, used where exposure to a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA enforcement records list no other recall actions for .
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