Recall Weekly
Moderate riskFDA DeviceClass II

GEM Premier 5000 PAK recalled for lysing solution concentration

Some lots of the GEM Premier 5000 PAK have a lysing bag solution whose active ingredient concentration did not meet manufacturing specifications. The notice says this could delay recognition and management of co-oximetry and total bilirubin abnormalities and their effects. The product was distributed nationwide in the US and in China, Germany and Italy.

From the FDA notice · Read the official notice ↗ · All Instrumentation Laboratory recalls

What to do

  1. Set aside affected GEM Premier 5000 PAK lots and stop using them for testing.
  2. Check each part number and lot against the notice, such as part 00055360010 with lots 260505K, 260504AG or 260505F, and part 00055360011 with lots 260505F or 260505J.
  3. Also check parts 00055407504, 00055415010, 00055430010, 00055430011, 00055445010, 00055445011 and 00055360010.A against their listed lots in the notice.
  4. The notice doesn't say how to get a replacement or refund; contact Instrumentation Laboratory for instructions.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected
109 units
Illnesses reported
None reported
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Classification
Class II
Recall number
Z-2900-2026

In the FDA's words

Description
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 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. Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF; Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy. Affected quantity: 109 units
Hazard
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 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.

2 products in this recall

GEM Premier 7000, 5000 PAK recalled for solution concentration

Instrumentation Laboratory is recalling 141 units of two blood analysis systems: 32 GEM Premier 7000 with iQM3 units and 109 GEM Premier 5000 PAK units. The active ingredient concentration in the lysing bag solution did not meet manufacturing specifications, which could delay recognition and management of co-oximetry and total bilirubin abnormalities. The FDA classified it as Class II, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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