Class II U.S. Food and Drug Administration

Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)

Recall published 7 months ago

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 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. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

The hazard: Impact or projectile hazard

An impact or projectile risk prompted this notice, and the injury it most often causes is to an eye.

What the notice says: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 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. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where…

Why it matters: The product can throw a part, release stored energy unexpectedly or strike the user. Eye injuries are the common outcome, and they are frequently permanent.

Symptoms and when to call a doctor

For an eye injury, do not rub the eye and do not try to remove anything embedded in it. Cover the eye with a shield that does not press on it — the bottom of a paper cup taped in place works — and get to an emergency department. For a blow to the head, watch for worsening headache, repeated vomiting, confusion or drowsiness, and call 911 if any of those appear.

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-1525-2026
Published
March 18, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Instrumentation Laboratory
Product type
Medical devices
Units affected
30 units
Distribution
Nationwide
Made in
United States
Lot / code info
Part number: 00055360008; UDI: 08426950807575; Lot No. 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E, 251229AG, 251229X.
UPC codes
08426950807575

Products covered by this recall

GEM Premier 5000 PAK; Part No. 00055360008.

Check your product

The notice names 9 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.

  • 08426950807575

Lot or batch code

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

  • 251021P
  • 251113U
  • 251117AD
  • 251204T
  • 251222U
  • 251223E
  • 251229AG
  • 251229

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 Impact

Instrumentation Laboratory — An impact or projectile risk prompted this notice, and the injury it most often causes is to an eye.

  1. Stop using the product and release any stored tension or pressure if the instructions describe a safe way to do it.
  2. Follow the remedy on this page and quote the model and date code from the label.
  3. Keep bystanders, and particularly children, away from it until the remedy is complete.
  4. Do not substitute your own parts or fasteners as a workaround.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.

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?

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 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. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 08426950807575; lot code 251021P, 251113U, 251117AD. 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?

Stop using the product and release any stored tension or pressure if the instructions describe a safe way to do it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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