FDA recall, Mar 10, 2026, Moderate risk

GEM Premier 5000

GEM Premier 5000 PAK may experience increased Process Control Solution Not Detected errors during warm-up, causing ejection and delays.

Summary by Recall Canary from the FDA notice

Instrumentation Laboratory, of Bedford, Massachusetts, began a recall on January 20, 2026, for GEM Premier 5000 and GEM Premier 5000 PAK products after confirmed customer complaints indicated that GEM PAKs may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK.

The FDA added the recall to its Enforcement Report on March 10, 2026, with distribution nationwide and worldwide, including the US and numerous other countries.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
Talk to your health care provider before you stop using it.

Is yours affected?

20 products

Affected if its UDI-DI, lot code and part code are listed under that product.

A UDI-DI is the device identifier printed with the barcode on the device label.

GEM Premier 5000; Part No. 00055415005.
UDI-DI
00055415005
08426950807667
Lot code
251125S
251201AJ
251212O
251218V
251229X
GEM Premier 5000 PAK, Part No. 00055360004.
UDI-DI
00055360004
08426950899662
Lot code
251113U
251201AI
251202Q
251223E
251223P
251229X
GEM Premier 5000; Part No. 00055415008.
UDI-DI
00055415008
08426950807674
Lot code
251021P
251106X
251110AF
251111O
251113J
251113V
251117AD
251118D
251124Z
251126Q
251201AJ
251202P
251204T
251212N
251215J
251215K
251223E
251229AG
251229X
GEM Premier 5000; Part No. 00055430008.
UDI-DI
00055430008
08426950807735
Lot code
251106X
251110AF
251202P
251203Q
251215J
251229AG
251229X
251230P
GEM Premier 5000 PAK; Part No. 00055407511.
UDI-DI
00055407511
08426950807643
Lot code
251114K
251201X
251215D
GEM Premier 5000; Model No. 00055430010.
UDI-DI
00055430010
08426950807759
Lot code
251021K
251027AA
251110AH
251114K
251114O
251114P
251114Y
251117AA
251117AC
251117AG
251117AM
251117AN
251117P
251117T
251117V
251117Y
251118A
251118B
251118R
251118X
251119A
251120R
251120U
251121Q
251124O
251124Q
251125I
251126S
251126T
251126U
251201W
251201X
251202G
251202H
251203L
251204R
251205L
251208N
251211W
251215D
251215Z
251216O
251216S
251217L
251217V
251218AB
251218B
251218X
251218Y
251219A
251219O
251222AE
251222E
251222F
251222K
251222M
251222P
251222Z
251223A
251223B
251223C
251223I
251223M
251223O
251229D
251229E
251229I
251229S
251231B
251231G
GEM Premier 5000; Part No. 00055445008.
UDI-DI
00055445008
08426950807797
Lot code
251103J
251110AF
251111O
251117AD
251201AJ
251202P
251202Q
251215K
GEM Premier 5000 PAK; Part No. 00055360011.
UDI-DI
00055360011
08426950807605
Lot code
251119A
GEM Premier 5000 PAK; Part No. 00055407510.
UDI-DI
00055407510
08426950807636
Lot code
251114J
251117AC
251117T
251118B
251119B
251121P
251124O
251124Q
251126E
251201U
251201V
251201W
251202G
251203H
251203L
251204N
251204O
251205L
251208I
251208J
251215Y
251215Z
251216V
251217L
251217X
251218AA
251218Y
251219G
251219M
251219N
251219S
251222E
251223D
251223I
251223N
251223O
251229J
251229L
251229U
251231E
GEM Premier 5000 PAK; Part No. 00055407508.
UDI-DI
00055407508
08426950807612
Lot code
251021P
251106X
251110AF
251201AJ
251202P
251209S
251212N
251215J
251218W
251219A
251223E
251223M
251223P
251229X
260102F
GEM Premier 5000; Part No. 00055430004.
UDI-DI
00055430004
08426950807711
Lot code
251111O
251113U
251117AD
251118D
251119D
251120X
251124Z
251125S
251201AI
251201AJ
251202P
251203Q
251208AA
251212O
251215J
251216K
251217I
251217J
251218V
251219R
251222T
251222U
251223E
251223P
251229AG
251229X
251230P
GEM Premier 5000
UDI-DI
00055415011
08426950807704
Part code
00055415011.
Lot code
251215D
GEM Premier 5000; Part No. 00055430011.
UDI-DI
00055430011
08426950807766
Lot code
251114K
251205K
251215D
GEM Premier 5000 PAK; Part No. 00055415004.
UDI-DI
00055415004
08426950807650
Lot code
251111O
251112P
251113U
251117AD
251118D
251119D
251120X
251124Z
251125S
251201AI
251202Q
251203Q
251208AA
251209T
251212O
251216K
251217I
251217J
251219R
251222U
251223E
251229AG
251229X
251230P
260102F
GEM Premier 5000; Part No. 00055445010 & 00055445011.
UDI-DI
00055445010
08426950807810
00055445011
08426950807827
Lot code
251023N
251024J
251114K
251117A
251117AC
251117AE
251117F
251117I
251117J
251117Y
251118A
251119A
251120U
251121Q
251121S
251121T
251121W
251121X
251124K
251124O
251124U
251125I
251126C
251126D
251202H
251203L
251203M
251204R
251204S
251205K
251205L
251208J
251208L
251215D
251215W
251215X
251216S
251216V
251217W
251217X
251218R
251218Y
251219B
251219C
251219E
251219H
251219I
251219P
251219Q
251223B
251223D
251223F
251223K
251229AL
251229D
251229E
251229F
251229S
251229U
251230R
251231B
251231D
251231E
251231H
251231M
251117L
251118O
251201X
251202G
251204O
251229W
251230A
GEM Premier 5000 PAK; Part No. 00055360010.
UDI-DI
00055360010
08426950807599
Lot code
251023N
251024I
251103I
251117T
251118B
251120R
251124O
251126E
251201X
251202E
251202G
251203H
251204O
251205L
251205N
251208C
251208G
251209Q
251209R
251215Y
251217V
251218AA
251218T
251219M
251222AE
251222AF
251222AG
251222E
251222F
251223R
251223S
251229H
251229J
251229U
251230A
251231E
251231K
251231L
GEM Premier 5000 PAK; Part No. 00055407504.
UDI-DI
00055407504
08426950807537
Lot code
251111O
251112P
251113U
251114T
251117AD
251118D
251119D
251120X
251125S
251126Q
251201AI
251202Q
251203Q
251204T
251209T
251212O
251215K
251216K
251217I
251218U
251219R
251222U
251223E
251223P
251229AG
251229X
251230P
251231F
GEM Premier 5000 PAK; Part No. 00055360008.
UDI-DI
00055360008
08426950807575
Lot code
251021P
251113U
251117AD
251204T
251222U
251223E
251229AG
251229X
GEM Premier 5000; Part No. 00055415010.
UDI-DI
00055415010
08426950807698
Lot code
251114J
251114K
251114L
251117AA
251117F
251117I
251117L
251117T
251118A
251118B
251118C
251119A
251119B
251124K
251126D
251126M
251126N
251126U
251201V
251202E
251202F
251203L
251204N
251204R
251205L
251208J
251211V
251211W
251215D
251215W
251216O
251216W
251217V
251219A
251219B
251219N
251219O
251219P
251219Q
251219S
251222AD
251222AF
251223D
251229AL
251229I
251229K
251229U
251230A
251230S
251231B
251231E
251231I
260102D
260105A
GEM Premier 5000; Part No. 00055445004.
UDI-DI
00055445004
08426950807773
Lot code
251111O
251117AD
251124Z
251125S
251202P
251204T
251208AA
251212O
251216K
251217I
251223E
251229AG
251229X
251230P

Recall details

Company began the recall

Jan 20, 2026

Sold in

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macau, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, San Marino, South Africa, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan & Vietnam.

Company

Instrumentation LaboratoryBedford, Massachusetts

Hazard

Device defect

Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID

98349

Recall numbers

Z-1524-2026 to Z-1543-2026

All recalls from Instrumentation Laboratory

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

Jan 20, 2026
Company began the recall
Mar 10, 2026
Added to FDA's Enforcement Report · Classified by FDA
Mar 18, 2026
In FDA's weekly enforcement report
Apr 23, 2026
Listed on Recall Canary
Oct 2, 2026
Summary updated

What happened

What to do

Is yours affected?

GEM Premier 5000; Part No. 00055415005.

GEM Premier 5000 PAK, Part No. 00055360004.

GEM Premier 5000; Part No. 00055415008.

GEM Premier 5000; Part No. 00055430008.

GEM Premier 5000 PAK; Part No. 00055407511.

GEM Premier 5000; Model No. 00055430010.

GEM Premier 5000; Part No. 00055445008.

GEM Premier 5000 PAK; Part No. 00055360011.

GEM Premier 5000 PAK; Part No. 00055407510.

GEM Premier 5000 PAK; Part No. 00055407508.

GEM Premier 5000; Part No. 00055430004.

GEM Premier 5000

GEM Premier 5000; Part No. 00055430011.

GEM Premier 5000 PAK; Part No. 00055415004.

GEM Premier 5000; Part No. 00055445010 & 00055445011.

GEM Premier 5000 PAK; Part No. 00055360010.

GEM Premier 5000 PAK; Part No. 00055407504.

GEM Premier 5000 PAK; Part No. 00055360008.

GEM Premier 5000; Part No. 00055415010.

GEM Premier 5000; Part No. 00055445004.

Recall details

Timeline

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