FDA recall, , Moderate risk
Instrumentation Laboratory GEM Premier 7000 and GEM Premier 5000 Blood Analyzers
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 and GEM Premier 5000 PAK lots did not meet established manufacturing specifications.
Summary by Recall Canary from the FDA notice
What happened
Instrumentation Laboratory of Bedford, Massachusetts recalled GEM Premier 5000 PAK and GEM Premier 7000 with iQM3 products because the active ingredient concentration in the lysing bag solution of specific lots did not meet established manufacturing specifications.
The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae. The recall began May 21, 2026, and was added to the FDA's Enforcement Report on August 6, 2026.
Distribution was worldwide, including the US states of Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Virginia, Wisconsin and West Virginia, and the countries of China, Germany, and Italy.
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?
2 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 PAK
- UDI-DI
- 00055360010
- 08426950807599
- 00055360011
- 08426950807605
- 00055407504
- 08426950807537
- 00055415010
- 08426950807698
- 00055430010
- 08426950807759
- 00055430011
- 08426950807766
- 00055445010
- 08426950807810
- 00055445011
- 08426950807827
- Part code
- 00055360010
- 00055360011
- 00055407504
- 00055415010
- 00055430010
- 00055430011
- 00055445010
- 00055445011
- 00055360010.A
- Lot code
- 260505K
- 260504AG
- 260505F
- 260505J
- 260505R
- 260505H
- 260504AA
- 260504AF
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The
- UDI-DI
- 00077407508
- 00195226000764
- 00077407510
- 00195226000665
- 00077415004
- 00195226000856
- 00077415008
- 00195226000757
- 00077415010
- 00195226000658
- 00077430010
- 00195226000641
- Lot code
- 260504E
- 260505B
- 260505A
- 260505C
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Virginia, Wisconsin, West Virginia and the countries of China, Germany, Italy.
- 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
- 99128
- Recall numbers
- Z-2899-2026 to Z-2900-2026
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.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
