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

The recall concerns stored energy — a spring, a pressurised part or a fast-moving component — released in a way the design did not intend.

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-1529-2026
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
180 units
Distribution
Nationwide
Made in
United States
Lot / code info
Part number: 00055407508; UDI: 08426950807612; Lots No.: 251021P, 251106X, 251110AF, 251201AJ, 251202P, 251209S, 251212N, 251215J, 251218W, 251219A, 251223E, 251223M, 251223P, 251229X, 260102F.
UPC codes
08426950807612

Products covered by this recall

GEM Premier 5000 PAK; Part No. 00055407508.

Check your product

The notice names 1 code 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.

  • 08426950807612

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 — The recall concerns stored energy — a spring, a pressurised part or a fast-moving component — released in a way the design did not intend.

  1. Stop using the product and release any stored tension or pressure if the instructions describe a safe way to do it.
  2. Do not substitute your own parts or fasteners as a workaround.
  3. Wear eye protection if you have to handle the item to pack it for return.
  4. Follow the remedy on this page and quote the model and date code from the label.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.

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 08426950807612. 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?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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