GEM Premier 5000 PAK part 00055407504 may eject during warm-up
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407504 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 PAK, part number 00055407504. About 489 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 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 08426950807537, across 28 lots beginning 251111O.
Laboratories can identify affected cartridges by the part number, UDI and lot numbers above, and may contact Instrumentation Laboratory for further information.
The recalled product
- Product
- GEM Premier 5000 PAK; Part No. 00055407504.
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 489
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)
- Lot Code: Part number: 00055407504
- UDI: 08426950807537
- Lots No.: 251111O
- 251112P
- 251113U
- 251114T
- 251117AD
- 251118D
- 251119D
- 251120X
- 251125S
- 251126Q
- 251201AI
- 251202Q
- 251203Q
- 251204T
- 251209T
- 251212O
- 251215K
- 251216K
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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