GEM Premier 5000 parts 00055445010 and 00055445011 may eject cartridges
Instrumentation Laboratory is recalling GEM Premier 5000 parts 00055445010 and 00055445011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source states results may be delayed and patient management may require reassessment, and no injuries are stated.
Plain-English summary
Instrumentation Laboratory is recalling the GEM Premier 5000, part numbers 00055445010 and 00055445011. About 1,989 units were distributed worldwide, covering the United States nationwide and more than sixty other countries. The FDA has classified this recall as Class II.
Confirmed customer complaints indicate that GEM PAKs (cartridges) may experience an increased incidence of "Process Control Solution Not Detected" errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. Consecutive ejections may prolong turnaround times, potentially delaying results, and patient management may require reassessment once results are available.
Part 00055445010 carries UDI 08426950807810 across 65 lots, and part 00055445011 carries UDI 08426950807827 across 11 lots, with 96 kits distributed in the United States.
Laboratories can identify affected units by the part numbers, UDIs and lot numbers above, and may contact Instrumentation Laboratory for further information.
The recalled product
- Product
- GEM Premier 5000; Part No. 00055445010 & 00055445011.
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 1,989
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part number: 00055445010
- UDI: 08426950807810
- Lots No.: 251023N
- 251024J
- 251114K
- 251117A
- 251117AC
- 251117AE
- 251117F
- 251117I
- 251117J
- 251117Y
- 251118A
- 251119A
- 251120U
- 251121Q
- 251121S
- 251121T
- 251121W
- 251121X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Instrumentation Laboratory under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
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