GEM Premier 5000 PAK part 00055415004 may eject during warm-up
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055415004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 00055415004. About 352 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 08426950807650, across 25 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. 00055415004.
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 352
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: 00055415004
- UDI: 08426950807650
- Lots No.: 251111O
- 251112P
- 251113U
- 251117AD
- 251118D
- 251119D
- 251120X
- 251124Z
- 251125S
- 251201AI
- 251202Q
- 251203Q
- 251208AA
- 251209T
- 251212O
- 251216K
- 251217I
- 251217J
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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