Class II U.S. Food and Drug Administration

Instrumentation Laboratory GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 recall: The active ingredient concentration in the lysing bag solution of specific

Recall published 2 months ago

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.

The hazard: Device malfunction

The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

What the notice says: 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.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2900-2026
Published
August 12, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Instrumentation Laboratory
Product type
Medical devices
Units affected
109 units
Distribution
Nationwide
Made in
United States
Lot / code info
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;
UPC codes
08426950807599, 08426950807605, 08426950807537, 08426950807698, 08426950807759, 08426950807766, 08426950807810, 08426950807827

Products covered by this recall

GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A

Check your product

The notice names 17 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 08426950807599
  • 08426950807605
  • 08426950807537
  • 08426950807698
  • 08426950807759
  • 08426950807766
  • 08426950807810
  • 08426950807827

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 260505K
  • 260504AG
  • 260505F
  • 260505J
  • 260505R
  • 260505H
  • 260504AA
  • 260504AF

Model or item number

On the rating label, the box or the instruction sheet.

  • 260

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Instrumentation Laboratory — The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  3. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  4. Report device problems to the FDA through MedWatch — that database is where this recall came from.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Instrumentation Laboratory — 180 Hartwell Rd, Bedford, MA, 01730-2443

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Instrumentation Laboratory medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 08426950807599, 08426950807605, 08426950807537; lot code 260505K, 260504AG, 260505F; model number 260. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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