GEM Premier 5000 part 00055430008 may eject cartridges during warm-up
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
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 number 00055430008. About 74 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.
Affected product carries UDI 08426950807735, across lots 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X and 251230P.
Laboratories can identify affected units by the part number, UDI and lot numbers above, and may contact Instrumentation Laboratory for further information.
The recalled product
- Product
- GEM Premier 5000; Part No. 00055430008.
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 74
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 (10)
- Part number: 00055430008
- UDI: 08426950807735
- Lots No.: 251106X
- 251110AF
- 251202P
- 251203Q
- 251215J
- 251229AG
- 251229X
- 251230P.
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.
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